CX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling CX Preconnect with TENACIO Pump without 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
CX Preconnect with TENACIO Pump without InhibiZone is being recalled, covering UPNs 72404486 (15CM IP) and 72404488 (21CM IP).
The recall concerns the potential for devices to experience inflation and/or deflation performance issues or difficulties.
The recall covers one unit. Affected product includes lots 1100676851 and 1100676852 for UPN 72404486. Distribution was worldwide, including 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
- CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1
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 (7)
- 1. UPN: 72404486 (15CM IP)
- UDI-DI: 00191506021658
- Lot numbers: 1100676851
- 1100676852
- 2. UPN: 72404488 (21CM IP)
- UDI-DI: 00191506021672
- Lot numbers: 1100717673
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12