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RecallWatchMedical Device Safety
Class IIOngoingZ-0142-2026

Boston Scientific Corporation recalls CX Preconnect with TENACIO Pump with InhibiZone

Boston Scientific CorporationMarlborough, MA, United StatesReported Oct 22, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);

Lot / code information

UDI
00191506021313
Lot #
1100489479, 1100489482, 1100553932, 1100553938, 1100553939, 1100559594 — +62 moreShow all
1100489479, 1100489482, 1100553932, 1100553938, 1100553939, 1100559594, 1100568472, 1100592190, 1100592195, 1100602356, 1100602384, 1100604224, 1100604257, 1100604936, 1100667673, 1100667677, 1100691423, 1100523050, 1100489473, 1100489476, 1100559588, 1100568474, 1100546165, 1100568477, 1100523054, 1100568478, 1100559592, 1100489475, 1100559590, 1100546163, 1100572777, 1100546162, 1100523055, 1100568476, 1100553937, 1100546160, 1100572771, 1100572772, 1100559595, 1100489478, 1100553936, 1100523051, 1100572769, 1100489477, 1100523049, 1100546159, 1100489474, 1100572773, 1100546164, 1100604225, 1100602381, 1100602351, 1100592189, 1100604227, 1100602383, 1100602379, 1100592191, 1100604262, 1100604260, 1100592196, 1100604259, 1100667670, 1100670795, 1100670801, 1100667671, 1100667679, 1100667678, 2. UPN: 72404431 (15CM PS IZ)
UDI
00191506021320
Lot #
1100488945, 1100488946, 1100488947, 1100488951, 1100488952, 1100488953 — +140 moreShow all
1100488945, 1100488946, 1100488947, 1100488951, 1100488952, 1100488953, 1100488954, 1100488981, 1100488982, 1100488983, 1100488984, 1100509688, 1100509689, 1100509690, 1100509693, 1100509694, 1100509695, 1100509706, 1100509711, 1100509714, 1100509716, 1100509717, 1100509719, 1100509724, 1100533744, 1100533745, 1100533749, 1100533751, 1100535545, 1100535546, 1100535552, 1100541422, 1100541423, 1100547735, 1100547736, 1100547738, 1100574742, 1100574743, 1100574747, 1100584464, 1100584466, 1100584467, 1100584468, 1100584470, 1100584471, 1100584472, 1100586699, 1100586701, 1100586702, 1100586705, 1100586706, 1100591067, 1100591068, 1100591069, 1100591073, 1100591074, 1100591075, 1100592675, 1100592682, 1100592683, 1100592684, 1100592704, 1100592705, 1100592708, 1100593462, 1100593464, 1100605249, 1100655173, 1100655178, 1100657280, 1100657281, 1100657282, 1100657287, 1100658348, 1100659230, 1100659238, 1100659642, 1100664225, 1100664227, 1100664240, 1100664242, 1100666373, 1100666379, 1100669912, 1100669913, 1100669914, 1100686427, 1100686429, 1100712803, 1100717712, 1100509718, 1100509709, 1100533742, 1100547739, 1100488985, 1100509705, 1100509710, 1100488986, 1100509691, 1100509715, 1100535551, 1100535550, 1100535549, 1100541426, 1100574748, 1100509723, 1100591070, 1100605251, 1100593460, 1100592680, 1100584473, 1100592677, 1100655175, 1100592702, 1100605253, 1100586704, 1100586707, 1100586703, 1100593467, 1100664223, 1100664237, 1100659649, 1100664235, 1100658342, 1100659641, 1100659233, 1100669911, 1100666376, 1100659640, 1100681641, 1100658340, 1100659648, 1100664239, 1100659234, 1100669910, 1100664224, 1100681636, 1100681640, 1100681637, 1100705558, 1100712802, 1100711033, 1100711021, 1100711030, 1100712801, 3. UPN: 72404432 (18CM PS IZ)
UDI
00191506021337
Lot #
1100479993, 1100479994, 1100479995, 1100479996, 1100479997, 1100479998 — +540 moreShow all
1100479993, 1100479994, 1100479995, 1100479996, 1100479997, 1100479998, 1100479999, 1100480000, 1100480001, 1100480002, 1100480065, 1100480066, 1100480067, 1100480068, 1100480069, 1100480070, 1100480071, 1100480072, 1100480073, 1100480074, 1100489410, 1100489411, 1100489412, 1100489413, 1100489414, 1100489415, 1100489416, 1100489417, 1100489418, 1100489419, 1100512428, 1100512429, 1100512430, 1100512431, 1100512432, 1100512433, 1100512434, 1100512435, 1100512436, 1100512437, 1100523699, 1100523700, 1100523701, 1100523702, 1100523703, 1100523704, 1100523705, 1100523706, 1100523707, 1100523708, 1100527833, 1100527834, 1100527835, 1100527836, 1100527837, 1100527838, 1100527839, 1100527844, 1100527845, 1100527846, 1100527847, 1100527848, 1100527849, 1100527850, 1100527851, 1100528338, 1100528339, 1100528340, 1100528341, 1100528342, 1100528343, 1100528344, 1100528345, 1100528346, 1100528348, 1100528349, 1100528350, 1100528351, 1100528352, 1100528353, 1100528354, 1100528355, 1100528357, 1100533030, 1100533031, 1100533033, 1100533034, 1100533035, 1100533036, 1100533037, 1100533038, 1100555849, 1100555850, 1100555851, 1100555852, 1100555853, 1100555854, 1100555855, 1100555856, 1100555857, 1100555858, 1100558200, 1100558201, 1100558202, 1100558203, 1100558204, 1100558205, 1100558206, 1100558207, 1100558209, 1100563070, 1100563071, 1100563072, 1100563073, 1100563074, 1100573189, 1100573190, 1100573191, 1100573192, 1100573193, 1100573194, 1100573195, 1100573196, 1100573197, 1100576167, 1100576168, 1100576169, 1100576170, 1100576171, 1100576172, 1100576174, 1100578222, 1100578223, 1100578225, 1100578226, 1100578227, 1100578228, 1100578229, 1100578230, 1100578231, 1100578232, 1100578233, 1100578234, 1100578235, 1100578236, 1100578238, 1100578239, 1100578240, 1100578241, 1100578278, 1100578280, 1100578282, 1100578283, 1100578284, 1100578285, 1100578286, 1100578566, 1100578568, 1100578569, 1100578570, 1100578571, 1100578572, 1100578573, 1100578574, 1100578575, 1100582068, 1100582069, 1100582070, 1100582071, 1100582072, 1100582074, 1100582075, 1100582076, 1100582077, 1100590135, 1100590136, 1100590137, 1100590138, 1100590139, 1100590140, 1100590141, 1100590142, 1100590143, 1100590144, 1100590190, 1100590191, 1100590192, 1100590193, 1100590194, 1100590195, 1100590196, 1100590197, 1100590198, 1100590199, 1100590975, 1100590976, 1100590977, 1100590978, 1100590979, 1100590980, 1100590981, 1100590982, 1100590983, 1100590984, 1100591028, 1100591029, 1100591030, 1100591031, 1100591032, 1100591033, 1100591034, 1100591035, 1100591036, 1100592732, 1100592733, 1100592734, 1100592735, 1100592736, 1100592737, 1100592738, 1100592739, 1100592740, 1100597245, 1100597246, 1100597247, 1100597248, 1100597250, 1100597251, 1100597252, 1100597253, 1100598427, 1100598428, 1100598429, 1100598431, 1100598432, 1100598433, 1100598434, 1100614950, 1100614951, 1100614952, 1100614953, 1100614954, 1100614957, 1100614958, 1100614959, 1100615312, 1100615313, 1100615314, 1100615315, 1100615316, 1100615317, 1100615318, 1100615319, 1100615320, 1100615635, 1100615636, 1100615637, 1100615638, 1100615639, 1100615640, 1100615642, 1100617815, 1100617817, 1100617818, 1100617819, 1100617820, 1100617821, 1100617822, 1100617823, 1100622709, 1100622710, 1100622711, 1100622712, 1100622713, 1100622714, 1100622715, 1100622716, 1100622717, 1100623591, 1100623592, 1100623594, 1100623595, 1100628785, 1100628786, 1100628787, 1100628788, 1100628789, 1100628790, 1100628791, 1100628793, 1100628794, 1100632022, 1100632023, 1100632024, 1100632025, 1100632026, 1100632027, 1100632028, 1100632030, 1100651848, 1100651849, 1100651850, 1100651851, 1100651852, 1100651853, 1100651855, 1100652180, 1100652181, 1100652182, 1100652186, 1100652187, 1100652188, 1100652190, 1100652191, 1100652192, 1100652193, 1100652194, 1100655635, 1100655636, 1100655637, 1100655638, 1100655639, 1100655640, 1100655641, 1100655642, 1100655643, 1100655644, 1100657267, 1100657268, 1100657269, 1100657270, 1100657272, 1100657274, 1100657276, 1100658241, 1100658242, 1100658243, 1100658245, 1100658246, 1100658247, 1100658248, 1100658249, 1100662686, 1100662687, 1100662688, 1100662691, 1100662692, 1100662693, 1100662694, 1100662695, 1100662723, 1100662725, 1100662727, 1100662728, 1100662729, 1100663420, 1100663421, 1100663422, 1100663423, 1100664157, 1100664158, 1100664160, 1100664161, 1100664163, 1100664164, 1100664165, 1100664166, 1100664177, 1100664178, 1100664180, 1100664181, 1100664182, 1100664183, 1100664185, 1100664186, 1100665250, 1100665254, 1100665255, 1100673302, 1100673303, 1100673305, 1100673307, 1100673308, 1100673309, 1100673311, 1100675398, 1100675399, 1100675400, 1100675401, 1100675402, 1100675403, 1100675405, 1100675406, 1100676776, 1100676778, 1100676779, 1100676780, 1100676781, 1100676782, 1100681563, 1100681564, 1100681565, 1100681566, 1100681567, 1100681568, 1100681570, 1100681571, 1100681623, 1100681625, 1100681627, 1100681628, 1100681630, 1100687984, 1100687985, 1100687986, 1100687987, 1100687988, 1100687989, 1100687991, 1100687992, 1100687993, 1100688032, 1100688033, 1100688037, 1100688038, 1100688039, 1100688040, 1100688742, 1100688743, 1100688744, 1100688745, 1100688746, 1100688747, 1100688748, 1100688749, 1100688750, 1100688751, 1100688752, 1100688753, 1100688754, 1100688755, 1100688756, 1100688757, 1100688759, 1100688761, 1100693136, 1100697385, 1100697387, 1100697388, 1100697389, 1100697390, 1100697391, 1100697393, 1100698109, 1100698110, 1100698112, 1100698114, 1100698116, 1100698117, 1100710476, 1100710477, 1100710480, 1100710481, 1100710483, 1100710498, 1100710499, 1100720978, 1100720980, 1100720985, 1100720986, 1100721733, 1100721737, 1100721739, 1100721742, 1100722256, 1100722261, 1100722263, 1100722265, 1100755419, 1100755420, 1100755421, 1100755422, 1100755423, 1100755424, 1100755425, 1100755426, 1100755427, 1100755428, 1100528356, 1100558208, 1100533032, 1100578281, 1100578224, 1100614955, 1100598430, 1100615641, 1100651854, 1100652184, 1100651846, 1100617816, …
UDI
00191506021344
Lot #
1100398859, 1100398860, 1100398861, 1100398862, 1100398863, 1100398864 — +809 moreShow all
1100398859, 1100398860, 1100398861, 1100398862, 1100398863, 1100398864, 1100398865, 1100398866, 1100398867, 1100399011, 1100399012, 1100399013, 1100399014, 1100399015, 1100399016, 1100399017, 1100399018, 1100399019, 1100480314, 1100480315, 1100480316, 1100480317, 1100480318, 1100480319, 1100480320, 1100480321, 1100480322, 1100480323, 1100480324, 1100480325, 1100480326, 1100480327, 1100480328, 1100480329, 1100480330, 1100480331, 1100480332, 1100480333, 1100480334, 1100480335, 1100480336, 1100480337, 1100480338, 1100480339, 1100480340, 1100480341, 1100480351, 1100480352, 1100480353, 1100480354, 1100480355, 1100480356, 1100480357, 1100480358, 1100480359, 1100480360, 1100489438, 1100489439, 1100489440, 1100489441, 1100489442, 1100489443, 1100489444, 1100489445, 1100489446, 1100489447, 1100491981, 1100491982, 1100491983, 1100491984, 1100509384, 1100509385, 1100509386, 1100509387, 1100509390, 1100509391, 1100509392, 1100509393, 1100512513, 1100512514, 1100512515, 1100512516, 1100512517, 1100512518, 1100512519, 1100512520, 1100512521, 1100512522, 1100523887, 1100523888, 1100523889, 1100523890, 1100523891, 1100523892, 1100523893, 1100523894, 1100523895, 1100523896, 1100526049, 1100526050, 1100526051, 1100526052, 1100526054, 1100526055, 1100526056, 1100526057, 1100526058, 1100527977, 1100527978, 1100527979, 1100527980, 1100527981, 1100527982, 1100527983, 1100527984, 1100527985, 1100527986, 1100530236, 1100530237, 1100530238, 1100530239, 1100530241, 1100530242, 1100532719, 1100532721, 1100532722, 1100532723, 1100532724, 1100532725, 1100532766, 1100532767, 1100532768, 1100532769, 1100532770, 1100532771, 1100532772, 1100532773, 1100532774, 1100532775, 1100532776, 1100532777, 1100532778, 1100532779, 1100532780, 1100532781, 1100535213, 1100535214, 1100535215, 1100535216, 1100535217, 1100535218, 1100535219, 1100535220, 1100535221, 1100535222, 1100535283, 1100535284, 1100535285, 1100535286, 1100535287, 1100535288, 1100535289, 1100535290, 1100535291, 1100535292, 1100537972, 1100537973, 1100537974, 1100537975, 1100537976, 1100537977, 1100537978, 1100537979, 1100537980, 1100537981, 1100538187, 1100538188, 1100538189, 1100538190, 1100538191, 1100538192, 1100538193, 1100538194, 1100538195, 1100538196, 1100540588, 1100540589, 1100540590, 1100540591, 1100545407, 1100545408, 1100545409, 1100545410, 1100545411, 1100545412, 1100545413, 1100545414, 1100545415, 1100545416, 1100556121, 1100556122, 1100556123, 1100556124, 1100556125, 1100556126, 1100556127, 1100556128, 1100556129, 1100556130, 1100556166, 1100556167, 1100556168, 1100556169, 1100556170, 1100556171, 1100556172, 1100556173, 1100556174, 1100556175, 1100573109, 1100573110, 1100573111, 1100573112, 1100573114, 1100573115, 1100573116, 1100573117, 1100574676, 1100574677, 1100574678, 1100574679, 1100574680, 1100574681, 1100574682, 1100574683, 1100574684, 1100574685, 1100574686, 1100574687, 1100574688, 1100574689, 1100574690, 1100574691, 1100574692, 1100574693, 1100574695, 1100574696, 1100574697, 1100574698, 1100574699, 1100574700, 1100574701, 1100574702, 1100574703, 1100574704, 1100574705, 1100574731, 1100574732, 1100574733, 1100574734, 1100574735, 1100574736, 1100574737, 1100574738, 1100578361, 1100578362, 1100578363, 1100578364, 1100578365, 1100578366, 1100578367, 1100578368, 1100578369, 1100578370, 1100578401, 1100578402, 1100578403, 1100578404, 1100578405, 1100578406, 1100578407, 1100578408, 1100578409, 1100578410, 1100579259, 1100579260, 1100579261, 1100579262, 1100579263, 1100579264, 1100579266, 1100579267, 1100579268, 1100579307, 1100579308, 1100579309, 1100579310, 1100579311, 1100579313, 1100579314, 1100579315, 1100584419, 1100584420, 1100584421, 1100584422, 1100584423, 1100584424, 1100584425, 1100584426, 1100584427, 1100584428, 1100584429, 1100584430, 1100584431, 1100584432, 1100584433, 1100584434, 1100584435, 1100584436, 1100584437, 1100584438, 1100586604, 1100586605, 1100586606, 1100586607, 1100586608, 1100586609, 1100586610, 1100586611, 1100586612, 1100586613, 1100591048, 1100591049, 1100591050, 1100591051, 1100591052, 1100591053, 1100591054, 1100591055, 1100591056, 1100591057, 1100594881, 1100594882, 1100594883, 1100594884, 1100594885, 1100594886, 1100594887, 1100594888, 1100594889, 1100595633, 1100595634, 1100595635, 1100595636, 1100595637, 1100595638, 1100595639, 1100595640, 1100595641, 1100595642, 1100595668, 1100595669, 1100595670, 1100595671, 1100595672, 1100595673, 1100595674, 1100595675, 1100595677, 1100595965, 1100595966, 1100595967, 1100595968, 1100595969, 1100595970, 1100595971, 1100595972, 1100595973, 1100608242, 1100608243, 1100608244, 1100608245, 1100608246, 1100614010, 1100614011, 1100614012, 1100614013, 1100614014, 1100614015, 1100614016, 1100614017, 1100615048, 1100615049, 1100615050, 1100615051, 1100615052, 1100615053, 1100615054, 1100615055, 1100615056, 1100617853, 1100617854, 1100617855, 1100617856, 1100617857, 1100617858, 1100617860, 1100617861, 1100620432, 1100620433, 1100620434, 1100620435, 1100620436, 1100620437, 1100620438, 1100620439, 1100620440, 1100620441, 1100621398, 1100621399, 1100621400, 1100621401, 1100621402, 1100621404, 1100621406, 1100621407, 1100621408, 1100621409, 1100621410, 1100621411, 1100621414, 1100621415, 1100621416, 1100621417, 1100622324, 1100622325, 1100622327, 1100622328, 1100622329, 1100622330, 1100622331, 1100622332, 1100622333, 1100623395, 1100623396, 1100623398, 1100623399, 1100623401, 1100623402, 1100623403, 1100623404, 1100626485, 1100626486, 1100626487, 1100626488, 1100626489, 1100626490, 1100626491, 1100626492, 1100626493, 1100653941, 1100653942, 1100653944, 1100653945, 1100653946, 1100653947, 1100653948, 1100653949, 1100653950, 1100653969, 1100653970, 1100653971, 1100653972, 1100653976, 1100653977, 1100653978, 1100655163, 1100655164, 1100655165, 1100655166, 1100655167, 1100655168, 1100655169, 1100655170, 1100655171, 1100655172, 1100655518, 1100655519, 1100655520, 1100655523, 1100655524, 1100655525, 1100655528, 1100655529, 1100655530, 1100655531, 1100655532, 1100655533, 1100655534, 1100655535, …
UDI
00191506021351
Lot #
1100404841, 1100404842, 1100404843, 1100404845, 1100404846, 1100404847 — +226 moreShow all
1100404841, 1100404842, 1100404843, 1100404845, 1100404846, 1100404847, 1100404848, 1100477638, 1100477639, 1100477640, 1100477645, 1100477646, 1100491851, 1100491853, 1100491855, 1100491856, 1100491857, 1100491858, 1100491860, 1100491871, 1100491873, 1100491875, 1100491878, 1100491880, 1100509760, 1100509761, 1100509762, 1100509765, 1100509768, 1100509769, 1100509770, 1100509773, 1100509775, 1100525451, 1100525452, 1100525453, 1100525455, 1100525457, 1100525458, 1100529589, 1100529591, 1100529594, 1100529596, 1100540597, 1100540599, 1100540600, 1100540601, 1100540602, 1100540603, 1100540604, 1100556285, 1100556286, 1100556287, 1100556289, 1100556290, 1100556292, 1100556445, 1100556446, 1100556447, 1100556450, 1100556451, 1100556452, 1100556718, 1100556719, 1100556720, 1100557301, 1100557303, 1100557304, 1100557305, 1100557306, 1100557308, 1100558477, 1100558481, 1100558484, 1100563642, 1100563643, 1100563644, 1100563646, 1100563648, 1100563650, 1100576003, 1100576004, 1100576005, 1100576009, 1100576010, 1100576011, 1100576012, 1100597147, 1100597148, 1100597149, 1100597151, 1100597153, 1100604264, 1100604265, 1100604270, 1100604271, 1100604272, 1100604273, 1100604274, 1100604275, 1100604276, 1100604279, 1100604282, 1100604284, 1100604285, 1100604286, 1100604290, 1100604293, 1100605225, 1100605226, 1100605230, 1100605231, 1100605233, 1100605234, 1100605236, 1100605239, 1100605241, 1100605242, 1100605243, 1100609900, 1100609901, 1100609902, 1100609903, 1100619616, 1100619617, 1100619618, 1100619620, 1100619622, 1100623375, 1100623376, 1100623377, 1100623380, 1100623382, 1100623383, 1100623603, 1100623607, 1100624278, 1100624279, 1100624280, 1100624282, 1100624283, 1100624284, 1100626379, 1100626380, 1100626381, 1100626382, 1100626386, 1100658076, 1100658077, 1100658081, 1100658082, 1100658153, 1100658155, 1100658158, 1100658159, 1100658162, 1100682726, 1100682729, 1100682732, 1100682733, 1100683460, 1100683462, 1100683465, 1100690141, 1100691010, 1100691013, 1100698164, 1100698172, 1100509774, 1100525459, 1100509758, 1100556717, 1100529593, 1100509757, 1100491876, 1100509767, 1100557302, 1100556716, 1100529592, 1100491872, 1100540596, 1100525450, 1100558485, 1100540605, 1100529595, 1100491874, 1100529590, 1100556284, 1100477643, 1100563649, 1100556448, 1100525454, 1100509776, 1100563647, 1100477641, 1100477642, 1100477644, 1100558480, 1100556449, 1100491854, 1100491877, 1100509763, 1100404844, 1100509764, 1100491852, 1100529598, 1100624285, 1100604269, 1100597150, 1100604289, 1100623602, 1100604291, 1100626378, 1100626383, 1100623381, 1100626384, 1100604277, 1100619619, 1100691017, 1100691019, 1100698166, 1100683463, 1100683458, 1100682725, 1100690134, 1100698163, 1100683459, 1100733032, 1100733035, 1100723233, 1100723237, 6. UPN: 72404435 (12CM IP IZ)
Show 10 more code fields
UDI
00191506021368
Lot #
1100556756, 1100562739, 1100492138, 1100570210, 1100570206, 1100570209 — +29 moreShow all
1100556756, 1100562739, 1100492138, 1100570210, 1100570206, 1100570209, 1100480148, 1100480143, 1100576373, 1100480151, 1100492133, 1100492134, 1100492135, 1100556757, 1100492130, 1100559507, 1100556758, 1100572095, 1100576374, 1100480145, 1100480144, 1100492131, 1100480147, 1100492129, 1100559511, 1100559509, 1100492137, 1100480150, 1100492136, 1100480149, 1100562742, 1100584865, 1100584845, 1100584840, 7. UPN: 72404436 (15CM IP IZ)
UDI
00191506021375
Lot #
1100490725, 1100490727, 1100490728, 1100490730, 1100490796, 1100490800 — +115 moreShow all
1100490725, 1100490727, 1100490728, 1100490730, 1100490796, 1100490800, 1100490802, 1100490803, 1100490804, 1100490809, 1100490810, 1100490812, 1100490813, 1100490815, 1100510307, 1100510308, 1100510309, 1100510310, 1100510311, 1100510314, 1100511326, 1100511328, 1100511329, 1100511330, 1100511331, 1100511332, 1100511334, 1100529987, 1100529989, 1100529992, 1100529993, 1100573909, 1100573910, 1100573911, 1100573912, 1100573915, 1100573916, 1100573917, 1100573918, 1100573962, 1100573963, 1100573965, 1100573970, 1100573971, 1100591122, 1100591123, 1100591126, 1100591130, 1100608586, 1100608587, 1100608589, 1100609479, 1100609481, 1100609482, 1100609485, 1100609487, 1100626431, 1100626433, 1100626438, 1100627625, 1100667324, 1100667327, 1100667633, 1100667640, 1100669896, 1100672734, 1100672735, 1100676767, 1100676768, 1100676770, 1100676771, 1100676772, 1100755478, 1100755479, 1100755480, 1100755481, 1100755482, 1100755483, 1100755484, 1100755485, 1100755486, 1100755487, 1100756184, 1100756185, 1100756186, 1100756187, 1100756188, 1100756189, 1100756190, 1100756191, 1100756192, 1100756193, 1100490722, 1100490805, 1100510313, 1100573966, 1100490799, 1100490798, 1100490723, 1100573968, 1100490729, 1100511335, 1100490801, 1100490726, 1100490724, 1100490797, 1100490731, 1100573967, 1100490806, 1100510312, 1100627629, 1100627623, 1100608592, 1100591131, 1100609484, 1100667641, 1100672732, 1100667328, 1100667647, 1100672736, 8. UPN: 72404437 (18CM IP IZ)
UDI
00191506021382
Lot #
1100404804, 1100404805, 1100404806, 1100404807, 1100404808, 1100404809 — +235 moreShow all
1100404804, 1100404805, 1100404806, 1100404807, 1100404808, 1100404809, 1100404810, 1100404811, 1100404812, 1100480258, 1100480260, 1100480261, 1100480263, 1100480264, 1100480265, 1100480266, 1100480267, 1100480286, 1100480287, 1100480288, 1100480289, 1100480290, 1100480291, 1100480292, 1100480293, 1100480294, 1100480295, 1100490852, 1100490853, 1100490854, 1100490855, 1100490856, 1100490857, 1100490858, 1100490859, 1100490860, 1100490861, 1100491398, 1100491399, 1100491400, 1100491401, 1100491402, 1100491403, 1100491404, 1100491405, 1100491406, 1100491407, 1100509557, 1100509558, 1100509559, 1100509560, 1100509561, 1100509562, 1100509563, 1100509564, 1100509566, 1100511277, 1100511278, 1100511279, 1100511280, 1100511281, 1100511282, 1100511283, 1100511284, 1100511285, 1100511286, 1100578557, 1100578558, 1100578559, 1100578560, 1100578561, 1100578562, 1100578565, 1100582058, 1100582060, 1100582061, 1100582062, 1100582063, 1100582064, 1100582065, 1100582066, 1100582067, 1100592712, 1100592713, 1100592714, 1100592715, 1100592716, 1100592717, 1100592719, 1100592720, 1100595604, 1100595605, 1100595606, 1100595607, 1100595608, 1100595609, 1100595610, 1100595611, 1100595612, 1100608252, 1100608254, 1100608256, 1100608257, 1100608258, 1100608259, 1100608260, 1100617834, 1100617835, 1100617837, 1100617838, 1100617839, 1100617840, 1100617841, 1100625079, 1100625080, 1100625081, 1100625082, 1100625083, 1100625084, 1100625085, 1100625086, 1100625087, 1100625088, 1100626505, 1100626506, 1100626509, 1100626510, 1100626511, 1100626512, 1100626513, 1100629386, 1100629387, 1100629389, 1100629392, 1100629393, 1100629394, 1100629395, 1100652235, 1100652238, 1100652239, 1100652240, 1100652241, 1100652242, 1100652243, 1100652244, 1100654680, 1100654682, 1100654683, 1100654684, 1100654685, 1100655683, 1100655684, 1100655685, 1100655687, 1100657546, 1100657548, 1100657549, 1100657550, 1100657551, 1100657552, 1100657553, 1100657554, 1100660305, 1100660306, 1100660308, 1100660309, 1100660310, 1100660311, 1100662676, 1100662677, 1100662678, 1100662680, 1100662682, 1100662683, 1100662684, 1100662685, 1100662758, 1100662760, 1100662765, 1100663409, 1100663412, 1100663413, 1100663415, 1100663416, 1100664169, 1100664170, 1100664173, 1100664174, 1100664175, 1100676796, 1100676798, 1100676799, 1100676800, 1100676802, 1100676803, 1100676804, 1100676805, 1100697420, 1100697421, 1100697423, 1100697425, 1100697426, 1100702534, 1100702535, 1100702537, 1100721026, 1100721028, 1100721031, 1100755960, 1100755961, 1100755962, 1100755963, 1100755964, 1100755965, 1100509565, 1100654679, 1100655686, 1100654681, 1100626508, 1100626514, 1100629391, 1100629390, 1100592711, 1100595613, 1100582059, 1100592718, 1100662681, 1100660307, 1100676801, 1100662679, 1100676797, 1100660304, 1100664172, 1100662762, 1100663414, 1100721030, 1100702533, 1100721027, 1100702530, 1100702532, 9. UPN: 72404438 (21CM IP IZ)
UDI
00191506021399
Lot #
1100399001, 1100399002, 1100399003, 1100399004, 1100399005, 1100399006 — +291 moreShow all
1100399001, 1100399002, 1100399003, 1100399004, 1100399005, 1100399006, 1100399007, 1100399008, 1100399009, 1100399010, 1100480612, 1100480613, 1100480614, 1100480615, 1100480616, 1100480618, 1100480619, 1100480620, 1100480621, 1100481570, 1100481571, 1100481572, 1100481573, 1100481574, 1100481575, 1100481576, 1100481577, 1100483215, 1100483216, 1100483217, 1100483218, 1100483219, 1100483220, 1100483221, 1100483222, 1100483223, 1100509468, 1100509469, 1100509470, 1100509471, 1100509472, 1100509473, 1100509474, 1100509475, 1100509485, 1100509486, 1100509487, 1100509488, 1100509489, 1100509490, 1100509491, 1100509492, 1100509493, 1100509529, 1100509530, 1100509531, 1100509532, 1100509533, 1100509534, 1100509535, 1100509536, 1100509537, 1100509538, 1100522035, 1100522036, 1100522037, 1100522038, 1100522039, 1100522040, 1100522041, 1100522042, 1100522043, 1100522044, 1100540606, 1100540607, 1100540608, 1100540609, 1100540610, 1100540611, 1100540612, 1100540613, 1100578391, 1100578392, 1100578393, 1100578394, 1100578395, 1100578396, 1100578397, 1100578398, 1100578399, 1100578400, 1100582121, 1100582122, 1100582123, 1100582124, 1100582125, 1100582126, 1100582127, 1100582128, 1100582129, 1100582130, 1100584349, 1100584350, 1100584351, 1100584352, 1100584354, 1100584355, 1100584357, 1100584358, 1100584904, 1100584905, 1100584906, 1100584907, 1100584908, 1100584909, 1100584910, 1100584911, 1100584912, 1100584913, 1100584934, 1100584935, 1100584936, 1100584937, 1100584938, 1100584939, 1100584940, 1100584941, 1100584942, 1100584943, 1100589998, 1100589999, 1100590000, 1100590001, 1100590003, 1100590005, 1100590006, 1100590007, 1100613893, 1100613894, 1100613895, 1100613896, 1100613897, 1100613898, 1100613899, 1100613900, 1100613901, 1100613902, 1100617890, 1100617891, 1100617893, 1100617895, 1100617897, 1100617898, 1100617899, 1100618997, 1100618998, 1100618999, 1100619000, 1100619001, 1100619003, 1100619004, 1100619005, 1100619006, 1100622334, 1100622335, 1100622336, 1100622337, 1100622338, 1100622339, 1100622341, 1100622342, 1100625099, 1100625100, 1100625101, 1100625102, 1100625104, 1100625106, 1100625107, 1100625108, 1100630645, 1100630646, 1100630647, 1100630648, 1100630649, 1100630650, 1100630651, 1100630652, 1100630653, 1100632103, 1100632104, 1100632105, 1100632106, 1100632107, 1100632108, 1100636846, 1100636847, 1100636849, 1100636851, 1100636852, 1100636853, 1100636854, 1100636855, 1100636876, 1100636877, 1100636878, 1100636879, 1100636880, 1100636882, 1100636883, 1100636884, 1100657390, 1100657391, 1100657393, 1100657394, 1100657399, 1100658033, 1100658034, 1100658035, 1100658036, 1100658037, 1100658038, 1100658039, 1100658041, 1100658042, 1100658921, 1100658922, 1100658923, 1100658924, 1100658925, 1100658926, 1100658927, 1100658928, 1100672665, 1100672666, 1100672667, 1100672670, 1100672672, 1100672673, 1100675958, 1100675964, 1100675967, 1100676951, 1100676952, 1100676953, 1100676954, 1100676955, 1100676956, 1100676957, 1100677576, 1100677577, 1100677578, 1100677580, 1100677582, 1100677583, 1100677584, 1100684979, 1100684980, 1100684981, 1100684984, 1100684985, 1100684986, 1100684987, 1100695734, 1100695738, 1100695739, 1100695741, 1100698582, 1100755429, 1100755430, 1100755431, 1100755432, 1100755433, 1100755434, 1100755435, 1100755436, 1100755437, 1100483214, 1100480617, 1100584353, 1100636881, 1100617896, 1100590004, 1100590002, 1100619002, 1100625103, 1100658929, 1100657398, 1100695736, 1100684983, 1100657396, 1100675959, 1100698581, 1100672671, 1100695740, 1100698578, 1100716476, 10. UPN: 72404439 (24CM IP IZ)
UDI
00191506021405
Lot #
1100398922, 1100398924, 1100398926, 1100398927, 1100398928, 1100398929 — +105 moreShow all
1100398922, 1100398924, 1100398926, 1100398927, 1100398928, 1100398929, 1100398930, 1100491865, 1100491866, 1100491868, 1100492099, 1100492100, 1100492101, 1100509782, 1100509786, 1100509787, 1100509788, 1100509791, 1100511268, 1100511276, 1100557385, 1100557387, 1100559426, 1100559429, 1100571285, 1100571287, 1100571290, 1100571291, 1100572297, 1100572298, 1100576051, 1100576053, 1100576056, 1100576057, 1100576058, 1100576059, 1100579707, 1100579711, 1100579712, 1100579713, 1100579716, 1100585009, 1100585012, 1100585014, 1100595679, 1100595684, 1100595685, 1100595686, 1100595687, 1100606722, 1100606723, 1100606725, 1100606726, 1100624252, 1100624254, 1100624255, 1100624256, 1100624257, 1100624259, 1100673252, 1100673978, 1100673981, 1100675235, 1100675242, 1100398921, 1100571284, 1100492098, 1100557384, 1100491862, 1100509783, 1100511271, 1100492095, 1100509789, 1100572296, 1100492097, 1100491870, 1100491867, 1100511269, 1100398923, 1100491861, 1100398925, 1100576060, 1100511274, 1100509790, 1100491869, 1100572295, 1100571289, 1100511270, 1100492096, 1100557388, 1100576054, 1100509784, 1100509785, 1100572302, 1100585013, 1100585016, 1100579710, 1100595678, 1100585008, 1100606727, 1100595683, 1100585015, 1100579708, 1100624253, 1100595681, 1100673984, 1100675237, 1100673983, 1100669362, 1100675238, 1100669359

What the firm is doing

On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device. - Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected devices that have been transferred to another organization.

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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