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RecallWatchMedical Device Safety
Class IOngoingZ-3150-2026

Abiomed, Inc. recalls Impella Optical Controller

Abiomed, Inc.Danvers, MA, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

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.

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

Lot / code information

UDI
00813502012972
Serial #
IC12674, IC12675, IC13066, IC10162, IC10163, IC10387 — +33 moreShow all
IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA
UDI
00813502012958
Serial #
IC10306, IC10312, IC11171, IC11172, IC12604, IC12605 — +21 moreShow all
IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU
UDI
00813502012217
Serial #
IC10382, IC10419, IC10681, IC10683, IC11123, IC11125 — +920 moreShow all
IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012, IC12015, IC12447, IC12483, IC12814, IC13029, IC13030, IC13031, IC9010, IC9011, IC9949, IC9950, IC10146, IC10180, IC10371, IC10372, IC10396, IC10397, IC10665, IC10670, IC10671, IC10673, IC10721, IC10772, IC10828, IC10835, IC11072, IC11116, IC11119, IC11132, IC11138, IC11140, IC11146, IC11679, IC11706, IC11712, IC11713, IC11721, IC11878, IC11951, IC11958, IC11967, IC11969, IC11978, IC11986, IC11992, IC11997, IC12260, IC12261, IC12446, IC12454, IC12458, IC12459, IC12463, IC12465, IC12466, IC12544, IC12546, IC12555, IC12565, IC12566, IC12586, IC12593, IC12594, IC12595, IC12596, IC12666, IC12670, IC12744, IC12747, IC12749, IC12750, IC12761, IC12764, IC12771, IC12810, IC12822, IC12828, IC12845, IC12929, IC13034, IC13035, IC13041, IC13047, IC13053, IC13118, IC13122, IC13135, IC13199, IC13226, IC13245, IC13246, IC13360, IC13364, IC13627, IC13635, IC13640, IC13642, IC12768, IC13023, IC13322, IC9071, IC9073, IC10126, IC10139, IC10169, IC10174, IC10392, IC10556, IC10558, IC10628, IC10632, IC10674, IC10677, IC10678, IC10680, IC11215, IC11217, IC11219, IC11220, IC11281, IC11283, IC11289, IC11358, IC11879, IC11904, IC11911, IC11930, IC11945, IC11952, IC11959, IC11960, IC11961, IC11966, IC11970, IC11973, IC11974, IC11976, IC11989, IC11991, IC12195, IC12206, IC12210, IC12213, IC12216, IC12217, IC12257, IC12258, IC12262, IC12265, IC12267, IC12269, IC12270, IC12272, IC12273, IC12274, IC12276, IC12277, IC12307, IC12309, IC12310, IC12319, IC12455, IC12456, IC12457, IC12467, IC12481, IC12484, IC12485, IC12488, IC12491, IC12494, IC12548, IC12551, IC12553, IC12765, IC12767, IC12812, IC12816, IC12824, IC12835, IC12942, IC12951, IC13177, IC13192, IC13291, IC13298, IC13328, IC13329, IC13330, IC13331, IC13352, IC13354, IC13363, IC13365, IC13366, IC13628, IC13636, IC9726, IC9727, IC9729, IC9730, IC9761, IC9830, IC9959, IC9965, IC10154, IC10159, IC10171, IC10175, IC10394, IC10400, IC10938, IC10952, IC11305, IC11715, IC11722, IC12001, IC12220, IC12221, IC12524, IC12542, IC12671, IC12672, IC8840, IC9252, IC9757, IC9759, IC10779, IC10782, IC10181, IC10184, IC10185, IC10186, IC10326, IC10360, IC10369, IC10540, IC10541, IC10544, IC10551, IC10555, IC10559, IC10627, IC10639, IC10679, IC10682, IC10707, IC10710, IC10711, IC10713, IC10809, IC11007, IC11010, IC11011, IC11090, IC11221, IC11223, IC11234, IC11363, IC11368, IC11717, IC11718, IC11719, IC11910, IC11913, IC11931, IC11948, IC11949, IC11955, IC11980, IC11983, IC12259, IC12263, IC12264, IC12266, IC12281, IC12282, IC12290, IC12311, IC12314, IC12486, IC12490, IC12496, IC12497, IC12576, IC12577, IC12695, IC12696, IC12697, IC12698, IC12699, IC12700, IC12702, IC12703, IC12704, IC12753, IC12754, IC12755, IC12756, IC12757, IC12802, IC12809, IC13069, IC13072, IC13120, IC13121, IC13133, IC13134, IC13136, IC13138, IC13165, IC13213, IC13248, IC13249, IC13281, IC13282, IC13293, IC13297, IC13371, IC13372, IC13565, IC13638, IC13639, IC13643, IC13645, IC13650, IC13653, IC8821, IC8822, IC8823, IC8825, IC8826, IC9002A, IC9015, IC9023, IC9024, IC9051, IC9052, IC9072, IC9076, IC9077, IC9078, IC9106, IC9107, IC9108, IC9109, IC9110, IC9111, IC9112, IC9113, IC9114, IC9115, IC9169, IC9171, IC9176, IC9216, IC9217, IC9251, IC9253, IC9257, IC9260, IC9342, IC9345, IC9352, IC9424, IC9427, IC9762, IC9763, IC9764, IC9765, IC9766, IC9824, IC9945, IC9948, IC13709, IC13710, IC13711, IC13712, IC10123, IC10124, IC10127, IC10138, IC10140, IC10141, IC10142, IC10143, IC10144, IC10148, IC10152, IC10155, IC10157, IC10158, IC10161, IC10166, IC10173, IC10176, IC10256, IC10257, IC10258, IC10259, IC10260, IC10261, IC10262, IC10263, IC10264, IC10265, IC10329, IC10347, IC10370, IC10389, IC10393, IC10395, IC10398, IC10401, IC10404, IC10408, IC10415, IC10416, IC10423, IC10424, IC10425, IC10433, IC10434, IC10437, IC10438, IC10439, IC10440, IC10442, IC10468, IC10506, IC10510, IC10542, IC10543, IC10552, IC10591, IC10621, IC10633, IC10634, IC10635, IC10636, IC10638, IC10720, IC10738, IC10767, IC10768, IC10778, IC10781, IC10819, IC10858, IC10870, IC10883, IC10884, IC10898, IC10909, IC10917, IC10919, IC10939, IC10943, IC10944, IC10945, IC10947, IC10948, IC10949, IC10953, IC10954, IC10955, IC11003, IC11004, IC11005, IC11009, IC11095, IC11120, IC11122, IC11124, IC11127, IC11133, IC11136, IC11137, IC11141, IC11142, IC11149, IC11193, IC11209, IC11214, IC11224, IC11225, IC11226, IC11228, IC11233, IC11235, IC11277, IC11278, IC11279, IC11280, IC11286, IC11287, IC11288, IC11322, IC11328, IC11332, IC11334, IC11360, IC11361, IC11364, IC11367, IC11699, IC11705, IC11707, IC11708, IC11709, IC11710, IC11711, IC11900, IC11909, IC11928, IC11929, IC11934, IC11937, IC11942, IC11943, IC11946, IC11947, IC11950, IC11953, IC11954, IC11956, IC11957, IC11962, IC11963, IC11971, IC11975, IC11977, IC11981, IC11984, IC11985, IC11987, IC11988, IC11993, IC11995, IC12002, IC12014, IC12208, IC12212, IC12219, IC12222, IC12223, IC12271, IC12275, IC12280, IC12287, IC12289, IC12291, IC12308, IC12312, IC12313, IC12320, IC12442, IC12451, IC12453, IC12464, IC12470, IC12487, IC12493, IC12495, IC12523, IC12536, IC12538, IC12541, IC12550, IC12554, IC12556, IC12558, IC12567, IC12568, IC12574, IC12575, IC12585, IC12590, IC12591, IC12597, IC12640, IC12648, IC12667, IC12668, IC12673, IC12751, IC12759, IC12760, IC12763, IC12805, IC12807, IC12811, IC12821, IC12827, IC12829, IC12833, IC12834, IC12854, IC12865, IC12939, IC12940, IC12941, IC12944, IC12946, IC12947, IC12948, IC13003, IC13026, IC13036, IC13081, IC13097, IC13098, IC13100, IC13101, IC13103, IC13104, IC13105, IC13106, IC13107, IC13119, IC13137, IC13178, IC13183, IC13186, IC13292, IC13295, IC13296, IC13318, IC13319, IC13321, IC13332, IC13353, IC13355, IC13359, IC13367, IC13369, IC13370, IC13374, IC13731, IC13741, IC13751, IC13752, IC13762, IC13775, IC13777, IC13778, IC13779, IC13780, IC13806, IC8818, IC8819, IC8820, IC8824, IC8827, IC8836, IC8837, IC8838, IC8839, IC8841, IC8842, IC8865, I …
UDI
00813502011814
Serial #
IC10016, IC10018, IC10019, IC10020, IC10021, IC10022 — +277 moreShow all
IC10016, IC10018, IC10019, IC10020, IC10021, IC10022, IC10068, IC10107, IC10119, IC10120, IC10272, IC10273, IC10274, IC10275, IC10276, IC10280, IC10290, IC10354, IC10355, IC10356, IC10357, IC10359, IC10363, IC10368, IC10405, IC10409, IC10413, IC10426, IC10427, IC10503, IC10504, IC10536, IC10537, IC10538, IC10539, IC10563, IC10583, IC10699, IC10700, IC10705, IC10806, IC10807, IC10810, IC10869, IC10906, IC10907, IC10928, IC10930, IC10931, IC10932, IC11088, IC11192, IC11195, IC11218, IC11253, IC11339, IC11340, IC11370, IC11376, IC11378, IC11405, IC11417, IC11453, IC11454, IC11459, IC11499, IC11570, IC11623, IC11636, IC11666, IC11672, IC11678, IC11687, IC11689, IC11690, IC11694, IC11720, IC11725, IC11727, IC11738, IC11743, IC11750, IC11751, IC11777, IC11778, IC12026, IC12028, IC12029, IC12030, IC12031, IC12404, IC12405, IC12434, IC12437, IC12438, IC12515, IC12516, IC12517, IC12518, IC12609, IC12610, IC12612, IC12613, IC12614, IC12617, IC12618, IC12619, IC12620, IC12752, IC12769, IC12775, IC12776, IC12841, IC12843, IC12846, IC12849, IC12852, IC12853, IC13258, IC13259, IC13324, IC13326, IC13392, IC13393, IC8196, IC8197, IC8237, IC8238, IC8239, IC8240, IC8241, IC8245, IC8246, IC8298, IC8299, IC8301, IC8302, IC8303, IC8304, IC8306, IC8309, IC8310, IC8364, IC8369, IC8370, IC8371, IC8372, IC8374, IC8375, IC8491, IC8492, IC8523, IC8524, IC8526, IC8531, IC8571, IC8573, IC8583, IC8595, IC8597, IC8599, IC8601, IC8619, IC8626, IC8666, IC8670, IC8679, IC8680, IC8681, IC8682, IC8684, IC8685, IC8687, IC8731, IC8732, IC8733, IC8734, IC8735, IC8779, IC8780, IC8782, IC8784, IC8785, IC8886, IC8887, IC8888, IC8889, IC8890, IC8892, IC8893, IC8894, IC8896, IC8897, IC8915, IC8916, IC8917, IC8918, IC8919, IC8921, IC8922, IC8923, IC8924, IC8927, IC8937, IC9125, IC9126, IC9127, IC9128, IC9129, IC9130, IC9131, IC9132, IC9134, IC9135, IC9136, IC9137, IC9138, IC9139, IC9140, IC9288, IC9289, IC9290, IC9291, IC9292, IC9294, IC9295, IC9298, IC9321, IC9322, IC9323, IC9325, IC9326, IC9329, IC9331, IC9332, IC9411, IC9462, IC9463, IC9485, IC9489, IC9490, IC9491, IC9492, IC9494, IC9495, IC9496, IC9497, IC9498, IC9499, IC9540, IC9559, IC9560, IC9561, IC9562, IC9563, IC9580, IC9694, IC9702, IC9703, IC9704, IC9705, IC9707, IC9708, IC9709, IC9786, IC9787, IC9790, IC9791, IC9811, IC9838, IC9894, IC9923, IC9925, IC9926, IC9927, IC9928, IC9929, IC9930, IC9931; 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK
UDI
00813502012484
Serial #
IC10008, IC10011, IC10025, IC10240, IC10241, IC10592 — +44 moreShow all
IC10008, IC10011, IC10025, IC10240, IC10241, IC10592, IC10593, IC10598, IC10601, IC11196, IC11197, IC11198, IC11640, IC11642, IC11645, IC11646, IC12714, IC12717, IC12725, IC12727, IC12728, IC9990, IC12255, IC10164, IC10165, IC12315, IC12318, IC12561, IC12563, IC12726, IC13338, IC10224, IC10225, IC10788, IC10789, IC10790, IC10792, IC10793, IC11723, IC11724, IC12256, IC12716, IC12718, IC13235, IC11682, IC11683; 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US
Show 2 more code fields
UDI
00813502011401
Serial #
IC10000, IC10001, IC10002, IC10003, IC10004, IC10005 — +2340 moreShow all
IC10000, IC10001, IC10002, IC10003, IC10004, IC10005, IC10006, IC10007, IC10009, IC10010, IC10026, IC10027, IC10028, IC10029, IC10030, IC10031, IC10036, IC10038, IC10041, IC10042, IC10045, IC10046, IC10047, IC10048, IC10050, IC10051, IC10052, IC10053, IC10054, IC10055, IC10056, IC10057, IC10058, IC10059, IC10060, IC10061, IC10062, IC10065, IC10067, IC10069, IC10070, IC10071, IC10072, IC10073, IC10074, IC10075, IC10076, IC10077, IC10078, IC10079, IC10080, IC10081, IC10082, IC10083, IC10084, IC10085, IC10086, IC10087, IC10088, IC10089, IC10090, IC10091, IC10092, IC10093, IC10094, IC10095, IC10096, IC10097, IC10098, IC10099, IC10100, IC10101, IC10104, IC10110, IC10111, IC10112, IC10113, IC10114, IC10115, IC10116, IC10117, IC10118, IC10128, IC10129, IC10130, IC10131, IC10132, IC10133, IC10134, IC10135, IC10136, IC10137, IC10147, IC10151, IC10187, IC10188, IC10189, IC10190, IC10191, IC10192, IC10193, IC10194, IC10195, IC10196, IC10197, IC10198, IC10199, IC10200, IC10201, IC10202, IC10203, IC10204, IC10205, IC10206, IC10207, IC10208, IC10209, IC10210, IC10211, IC10212, IC10213, IC10214, IC10215, IC10216, IC10217, IC10218, IC10219, IC10220, IC10221, IC10222, IC10223, IC10226, IC10227, IC10228, IC10229, IC10230, IC10231, IC10232, IC10233, IC10235, IC10237, IC10242, IC10246, IC10247, IC10248, IC10249, IC10250, IC10251, IC10252, IC10253, IC10254, IC10255, IC10266, IC10269, IC10271, IC10277, IC10279, IC10282, IC10283, IC10284, IC10285, IC10286, IC10287, IC10288, IC10289, IC10291, IC10292, IC10293, IC10294, IC10295, IC10296, IC10297, IC10298, IC10299, IC10301, IC10303, IC10304, IC10307, IC10308, IC10309, IC10310, IC10311, IC10313, IC10314, IC10315, IC10316, IC10317, IC10321, IC10322, IC10323, IC10324, IC10325, IC10327, IC10328, IC10330, IC10331, IC10332, IC10333, IC10334, IC10335, IC10336, IC10337, IC10339, IC10340, IC10342, IC10343, IC10344, IC10345, IC10346, IC10348, IC10349, IC10350, IC10351, IC10352, IC10358, IC10361, IC10373, IC10374, IC10375, IC10376, IC10377, IC10378, IC10379, IC10380, IC10381, IC10383, IC10384, IC10385, IC10386, IC10390, IC10391, IC10407, IC10410, IC10412, IC10418, IC10420, IC10421, IC10422, IC10428, IC10429, IC10430, IC10431, IC10432, IC10435, IC10436, IC10443, IC10444, IC10445, IC10446, IC10447, IC10448, IC10449, IC10450, IC10451, IC10452, IC10453, IC10454, IC10455, IC10459, IC10461, IC10462, IC10466, IC10470, IC10471, IC10472, IC10474, IC10475, IC10476, IC10477, IC10478, IC10479, IC10480, IC10481, IC10482, IC10484, IC10485, IC10486, IC10487, IC10509, IC10511, IC10512, IC10514, IC10515, IC10516, IC10519, IC10520, IC10521, IC10522, IC10523, IC10524, IC10525, IC10526, IC10527, IC10528, IC10529, IC10530, IC10531, IC10532, IC10533, IC10534, IC10535, IC10545, IC10546, IC10548, IC10549, IC10550, IC10553, IC10554, IC10557, IC10561, IC10562, IC10564, IC10565, IC10566, IC10567, IC10568, IC10569, IC10570, IC10571, IC10572, IC10578, IC10581, IC10582, IC10596, IC10597, IC10599, IC10600, IC10602, IC10603, IC10604, IC10605, IC10606, IC10607, IC10608, IC10609, IC10610, IC10611, IC10612, IC10613, IC10614, IC10615, IC10616, IC10617, IC10618, IC10619, IC10620, IC10622, IC10623, IC10624, IC10625, IC10626, IC10637, IC10642, IC10643, IC10644, IC10647, IC10653, IC10654, IC10655, IC10656, IC10657, IC10658, IC10659, IC10660, IC10661, IC10662, IC10669, IC10684, IC10685, IC10687, IC10688, IC10690, IC10691, IC10692, IC10693, IC10694, IC10695, IC10696, IC10697, IC10704, IC10708, IC10709, IC10712, IC10714, IC10715, IC10716, IC10717, IC10718, IC10719, IC10722, IC10723, IC10724, IC10725, IC10726, IC10728, IC10729, IC10730, IC10731, IC10732, IC10733, IC10734, IC10736, IC10737, IC10739, IC10740, IC10741, IC10742, IC10743, IC10744, IC10745, IC10746, IC10749, IC10750, IC10751, IC10752, IC10753, IC10754, IC10756, IC10757, IC10758, IC10759, IC10760, IC10763, IC10764, IC10769, IC10770, IC10774, IC10776, IC10777, IC10783, IC10787, IC10791, IC10795, IC10796, IC10800, IC10811, IC10812, IC10813, IC10814, IC10815, IC10816, IC10817, IC10818, IC10821, IC10822, IC10823, IC10824, IC10825, IC10826, IC10830, IC10831, IC10832, IC10833, IC10838, IC10839, IC10842, IC10845, IC10847, IC10848, IC10850, IC10852, IC10855, IC10856, IC10857, IC10859, IC10860, IC10861, IC10873, IC10875, IC10876, IC10877, IC10878, IC10879, IC10880, IC10881, IC10888, IC10895, IC10897, IC10899, IC10900, IC10901, IC10908, IC10910, IC10911, IC10912, IC10913, IC10915, IC10918, IC10922, IC10923, IC10924, IC10925, IC10926, IC10927, IC10929, IC10934, IC10935, IC10936, IC10937, IC10941, IC10957, IC10958, IC10959, IC10962, IC10971, IC10972, IC10974, IC10975, IC10978, IC10980, IC10981, IC10982, IC10998, IC10999, IC11001, IC11002, IC11008, IC11012, IC11013, IC11014, IC11016, IC11017, IC11018, IC11021, IC11022, IC11024, IC11030, IC11031, IC11032, IC11033, IC11034, IC11035, IC11036, IC11037, IC11038, IC11039, IC11040, IC11041, IC11042, IC11043, IC11044, IC11045, IC11046, IC11047, IC11051, IC11052, IC11053, IC11054, IC11056, IC11058, IC11059, IC11060, IC11062, IC11063, IC11064, IC11065, IC11066, IC11068, IC11069, IC11070, IC11073, IC11075, IC11076, IC11077, IC11078, IC11079, IC11080, IC11081, IC11082, IC11085, IC11087, IC11092, IC11093, IC11094, IC11096, IC11103, IC11106, IC11107, IC11108, IC11109, IC11117, IC11129, IC11139, IC11147, IC11150, IC11154, IC11155, IC11156, IC11157, IC11158, IC11159, IC11160, IC11161, IC11163, IC11164, IC11165, IC11166, IC11167, IC11168, IC11169, IC11170, IC11173, IC11175, IC11176, IC11178, IC11179, IC11180, IC11181, IC11184, IC11185, IC11187, IC11188, IC11189, IC11191, IC11194, IC11200, IC11203, IC11205, IC11206, IC11207, IC11208, IC11241, IC11242, IC11243, IC11244, IC11245, IC11246, IC11247, IC11249, IC11251, IC11268, IC11269, IC11270, IC11271, IC11272, IC11273, IC11274, IC11275, IC11276, IC11284, IC11285, IC11290, IC11291, IC11292, IC11293, IC11294, IC11295, IC11296, IC11297, IC11298, IC11310, IC11312, IC11313, IC11314, IC11315, IC11316, IC11318, IC11319, IC11320, IC11327, IC11333, IC11335, IC11347, IC11348, IC11349, IC11350, IC1135 …
Additional code information

, IC9205, IC9206, IC9207, IC9208, IC9209, IC9210, IC9211, IC9212, IC9213, IC9214, IC9218, IC9219, IC9220, IC9221, IC9222, IC9223, IC9224, IC9225, IC9226, IC9227, IC9231, IC9232, IC9243, IC9244, IC9245, IC9246, IC9247, IC9248, IC9249, IC9250, IC9266, IC9267, IC9268, IC9269, IC9270, IC9271, IC9272, IC9273, IC9274, IC9275, IC9276, IC9277, IC9278, IC9279, IC9280, IC9282, IC9283, IC9284, IC9285, IC9286, IC9287, IC9300, IC9301, IC9302, IC9303, IC9304, IC9305, IC9306, IC9307, IC9308, IC9309, IC9310, IC9311, IC9312, IC9313, IC9314, IC9315, IC9316, IC9317, IC9318, IC9319, IC9327, IC9333, IC9334, IC9335, IC9337, IC9338, IC9339, IC9350, IC9351, IC9353, IC9355, IC9357, IC9359, IC9360, IC9361, IC9362, IC9373, IC9374, IC9375, IC9376, IC9377, IC9378, IC9379, IC9380, IC9381, IC9382, IC9405, IC9406, IC9408, IC9409, IC9410, IC9412, IC9418, IC9421, IC9422, IC9423, IC9451, IC9452, IC9453, IC9454, IC9455, IC9456, IC9457, IC9458, IC9460, IC9461, IC9465, IC9466, IC9467, IC9468, IC9469, IC9470, IC9471, IC9472, IC9473, IC9474, IC9475, IC9476, IC9477, IC9478, IC9479, IC9480, IC9481, IC9482, IC9483, IC9484, IC9486, IC9488, IC9493, IC9510, IC9511, IC9512, IC9513, IC9514, IC9515, IC9516, IC9517, IC9518, IC9519, IC9520, IC9521, IC9522, IC9523, IC9524, IC9525, IC9526, IC9527, IC9528, IC9530, IC9532, IC9533, IC9534, IC9535, IC9536, IC9537, IC9538, IC9539, IC9541, IC9542, IC9543, IC9544, IC9545, IC9546, IC9547, IC9548, IC9549, IC9550, IC9551, IC9567, IC9571, IC9572, IC9573, IC9574, IC9575, IC9576, IC9577, IC9578, IC9579, IC9582, IC9583, IC9585, IC9586, IC9587, IC9588, IC9589, IC9594, IC9596, IC9597, IC9598, IC9606, IC9607, IC9608, IC9609, IC9611, IC9612, IC9613, IC9614, IC9617, IC9618, IC9619, IC9620, IC9621, IC9625, IC9649, IC9650, IC9651, IC9652, IC9653, IC9654, IC9655, IC9656, IC9657, IC9658, IC9659, IC9660, IC9661, IC9662, IC9663, IC9665, IC9666, IC9667, IC9668, IC9669, IC9670, IC9671, IC9672, IC9673, IC9675, IC9676, IC9677, IC9678, IC9679, IC9680, IC9681, IC9682, IC9683, IC9684, IC9685, IC9686, IC9688, IC9691, IC9697, IC9698, IC9699, IC9700, IC9701, IC9710, IC9711, IC9712, IC9713, IC9714, IC9715, IC9716, IC9717, IC9718, IC9719, IC9720, IC9721, IC9722, IC9723, IC9724, IC9725, IC9731, IC9733, IC9734, IC9735, IC9736, IC9737, IC9738, IC9739, IC9740, IC9741, IC9742, IC9743, IC9747, IC9748, IC9749, IC9750, IC9751, IC9752, IC9753, IC9754, IC9755, IC9756, IC9768, IC9769, IC9770, IC9771, IC9772, IC9774, IC9775, IC9776, IC9778, IC9779, IC9792, IC9794, IC9795, IC9806, IC9807, IC9808, IC9809, IC9810, IC9812, IC9823, IC9825, IC9826, IC9829, IC9831, IC9836, IC9837, IC9839, IC9840, IC9841, IC9842, IC9843, IC9844, IC9845, IC9846, IC9847, IC9848, IC9849, IC9850, IC9851, IC9852, IC9853, IC9854, IC9855, IC9856, IC9857, IC9858, IC9859, IC9860, IC9861, IC9862, IC9863, IC9864, IC9869, IC9870, IC9871, IC9872, IC9873, IC9874, IC9875, IC9876, IC9877, IC9878, IC9879, IC9880, IC9881, IC9882, IC9883, IC9884, IC9885, IC9886, IC9887, IC9888, IC9899, IC9900, IC9903, IC9904, IC9906, IC9907, IC9909, IC9910, IC9911, IC9912, IC9913, IC9914, IC9916, IC9917, IC9918, IC9920, IC9924, IC9932, IC9933, IC9934, IC9935, IC9936, IC9937, IC9938, IC9939, IC9940, IC9941, IC9963, IC9975, IC9976, IC9977, IC9978, IC9979, IC9980, IC9982, IC9983, IC9984, IC9985, IC9986, IC9987, IC9988, IC9991, IC9992, IC9993, IC9994, IC9995, IC9997, IC9999, IC11516, IC11819, IC12615, IC12627, IC13313, IC13315, IC13696, IC10547, IC10844, IC11055, IC11089, IC11091, IC11097, IC11151, IC11152, IC11494, IC12245, IC12248, IC13505, IC13560, IC13630, IC13633, IC8880, IC9036, IC9464; 7. Product Code: 0042-0040-KR; UDI-DI: 00813502013160; Serial Numbers: IC13611, IC13612, IC13613, IC13614, IC13615, IC13616, IC13722, IC13723, IC13724, IC13725;

What the firm is doing

On August 12, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions to be Taken: 1. Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care. 2. Abiomed s field service team will contact you to schedule the specified replacement. 3. In the event of these purge flag component failures and associated alarms, as per IFU, first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. 4. Ensure cleaning of the AIC housing with mild detergent as specified in the IFU. 5. Ensure future routine preventive maintenance is performed annually on your AIC(s) following the guidance in the IFU 6. Forward this notice to anyone in your facility that needs to be informed. 7. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 8. Post a copy of this notice in a visible area for awareness.

DistributionShow details

Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

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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