CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);
FDA Recall Z-0142-2026 · Posted 2025-10-10
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Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeJCW
Date Initiated2025-09-11
Product Quantity2288 units
Reason for Recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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