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.
What this means for you
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), (9
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- inflation-failure
- implant
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.
Related recalls
Same category
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22