FDA-Device2025-10-22Class II
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);
Hazard
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
2288 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
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);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2026More Boston Scientific Corporation recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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