medical Class I Updated 2024-11-20

Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER ST US, Materia

Recalled Product

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060


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 08714729992622
View official government recall

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