Device product

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Z-0301-2025

October 10, 2024

Class I

Product summary

Firm: Boston Scientific Corporation
Event: Event 95514
Status: Ongoing
Classification: Class I
Quantity: 2751 units
Official record key: device-enforcement:Z-0301-2025

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: GTIN00191506016456

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.