Preconnect pump devices recalled over inflation and deflation performance issues
Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an implanted device that may not inflate or deflate as intended is a clinical risk, and no injuries are reported.
Plain-English summary
CXR Preconnect with TENACIO Pump with InhibiZone is being recalled across UPNs including 72404461 (12CM PS IZ), 72404462 (14CM PS IZ), 72404463 (16CM PS IZ), 72404464 (18CM PS IZ), 72404465 (10CM IP IZ), 72404466 (12CM IP IZ) and 72404467 (14CM IP IZ).
The recall concerns the potential for devices to experience inflation and/or deflation performance issues or difficulties.
The recall covers 172 units, distributed nationwide in the United States and to Canada. The FDA has classified the action as Class II.
The enforcement record describes the performance issue and reports no injuries. Facilities holding affected lot numbers should follow Boston Scientific's instructions.
The recalled product
- Product
- 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)…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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