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Boston Scientific Corporation recalls Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Recalled November 20, 2024 · FDA recall Z-0302-2025 · Boston Scientific
Hazard
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. · FDA Class I
Units
368 units
Sold at
Worldwide
Description
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →