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RecallWatchMedical Device Safety
Class IIOngoingZ-0143-2026

Boston Scientific Corporation recalls CXR 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.

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

Lot / code information

UDI
00191506021504
Lot #
1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873 — +45 moreShow all
1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ)
UDI
00191506021511
Lot #
1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549 — +54 moreShow all
1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714, 1100605715, 1100609592, 1100613514, 1100621453, 1100621454, 1100625387, 1100625388, 1100625391, 1100522433, 1100489493, 1100489492, 1100489495, 1100543858, 1100489546, 1100489494, 1100489496, 1100543859, 1100543864, 1100489497, 1100625392, 1100625394, 1100613511, 1100605718, 1100625393, 1100602694, 1100599203, 1100609585, 1100602695, 1100605709, 1100605710, 1100602564, 1100599196, 1100677511, 1100677506, 1100677507, 1100677509, 1100715069, 3. UPN: 72404463 (16CM PS IZ)
UDI
00191506021528
Lot #
1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567 — +98 moreShow all
1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567, 1100492188, 1100511647, 1100511648, 1100511652, 1100511653, 1100511654, 1100511655, 1100511705, 1100511711, 1100546879, 1100546880, 1100546881, 1100551274, 1100551275, 1100551276, 1100551280, 1100560945, 1100560950, 1100565155, 1100565156, 1100565163, 1100565574, 1100565578, 1100565579, 1100565580, 1100565629, 1100565632, 1100565634, 1100565635, 1100602136, 1100602140, 1100602194, 1100602195, 1100602197, 1100602227, 1100602228, 1100602229, 1100605207, 1100605211, 1100605214, 1100614920, 1100615585, 1100615587, 1100619169, 1100619173, 1100619174, 1100657322, 1100657324, 1100657325, 1100511649, 1100565159, 1100511709, 1100560952, 1100480550, 1100480568, 1100565581, 1100492184, 1100546878, 1100546876, 1100546877, 1100546875, 1100480557, 1100511650, 1100511704, 1100480553, 1100480552, 1100480558, 1100480551, 1100511702, 1100511651, 1100511703, 1100480556, 1100565631, 1100560953, 1100605206, 1100602225, 1100602196, 1100614923, 1100602192, 1100602223, 1100606735, 1100615594, 1100615588, 1100614926, 1100619170, 1100615590, 1100615589, 1100602193, 1100602199, 1100602201, 1100605210, 1100690401, 1100657331, 1100657330, 1100663408, 1100663399, 1100657326, 4. UPN: 72404464 (18CM PS IZ)
UDI
00191506021535
Lot #
1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ)
UDI
00191506021542
Lot #
1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ)
Show 8 more code fields
UDI
00191506021559
Lot #
1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540 — +37 moreShow all
1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100556794, 1100491464, 1100491466, 1100573736, 1100491465, 1100573773, 1100491472, 1100565103, 1100573739, 1100512182, 1100554190, 1100512180, 1100491470, 1100491471, 1100491467, 1100512183, 1100554188, 1100556786, 1100573737, 1100573738, 1100491463, 1100573774, 1100512181, 1100573732, 1100491469, 1100573730, 1100491468, 1100554187, 1100627360, 1100627357, 1100627355, 1100668336, 1100668329, 1100668337, 7. UPN: 72404467 (14CM IP IZ)
UDI
00191506021566
Lot #
1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072 — +30 moreShow all
1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072, 1100626261, 1100512197, 1100554148, 1100492110, 1100512198, 1100569181, 1100572069, 1100569180, 1100556843, 1100554150, 1100569165, 1100556842, 1100492104, 1100574559, 1100569179, 1100569161, 1100554146, 1100492103, 1100512202, 1100512196, 1100574566, 1100572068, 1100569159, 1100556839, 1100512201, 1100569184, 1100626262, 1100585076, 1100626260, 8. UPN: 72404468 (16CM IP IZ)
UDI
00191506021573
Lot #
1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905 — +46 moreShow all
1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905, 1100560907, 1100569608, 1100569612, 1100569649, 1100569656, 1100573275, 1100574054, 1100574055, 1100574058, 1100574059, 1100574062, 1100624980, 1100624983, 1100624987, 1100624988, 1100626293, 1100626296, 1100554173, 1100560903, 1100524760, 1100573278, 1100569609, 1100490867, 1100569610, 1100524761, 1100560908, 1100554175, 1100560197, 1100574056, 1100569605, 1100554177, 1100574057, 1100574060, 1100490863, 1100560900, 1100569648, 1100573273, 1100573269, 1100569604, 1100560906, 1100569657, 1100524758, 1100626288, 1100626295, 1100626292, 9. UPN: 72404469 (18CM IP IZ)
UDI
00191506021580
Lot #
1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973

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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