Recall Z-0143-2026— Boston Scientific Corporation

Name: FDA recall Z-0143-2026
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: 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) 72404469 (18CM 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

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) 72404469 (18CM 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.