medical Class I Updated 2024-11-20

Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Mater

Recalled Product

Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: GTIN 08714729992660
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →