CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- Company
- Boston Scientific Corporation
- Recall Initiated
- September 11, 2025
- Posted
- October 10, 2025
- Recall Number
- Z-0140-2026
- Quantity
- 1 unit
- Firm Location
- Marlborough, MA
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.
Lot / Code Info
1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;
Root Cause
Nonconforming Material/Component
Action Taken
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.