Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Mater
Recalled Product
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
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 08714729992578
View official government recall
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