Class II Recall

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3)

Summary

The FDA issued a Class II for CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM by Boston Scientific Corporation. Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties..

Details

Source

Device Recall

External ID

Z-0143-2026

Action Date

2025-10-22

Status

Ongoing

Product Description

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 Info: 1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 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-DI: 00191506021511; Lot numbers: 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-DI: 00191506021528; Lot numbers: 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-DI: 00191506021535; Lot numbers: 1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ); UDI-DI: 00191506021542; Lot numbers: 1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ); UDI-DI: 00191506021559; Lot numbers: 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-DI: 00191506021566; Lot numbers: 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-DI: 00191506021573; Lot numbers: 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-DI: 00191506021580; Lot numbers: 1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973,

Quantity Affected: 172 units

Reason for Recall

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

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-09-11

Company

Boston Scientific Corporation

Marlborough, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 237 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Boston Scientific Corporation have FDA actions?

Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0143-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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