Device product
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Z-0302-2025
Product summary
- Event
- Event 95514
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 368 units
- Official record key
device-enforcement:Z-0302-2025
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 00191506016463
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.