medical Class I Updated 2024-11-20

Boston Scientific Corporation recalls Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Mat

Recalled Product

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

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 08714729992691
View official government recall

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