Device product
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Z-0303-2025
Product summary
- Event
- Event 95514
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1035 units
- Official record key
device-enforcement:Z-0303-2025
Official wording
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Code information: GTIN 08714729992691
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.