Device product

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

Z-0297-2025

October 10, 2024

Class I

Product summary

Firm: Boston Scientific Corporation
Event: Event 95514
Status: Ongoing
Classification: Class I
Quantity: 4422 units
Official record key: device-enforcement:Z-0297-2025

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 08714729992561

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.