Recall Z-0142-2026— Boston Scientific Corporation

Name: FDA recall Z-0142-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2025-09-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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);. Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-09-11
Firm location: Marlborough, MA, United States

Product description

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);

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Data sourced from openFDA. This site is unofficial and independent of the FDA.