Class I
Medical Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Boston Scientific Corporation · October 10, 2024
Reason for Recall
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Distribution
Worldwide
Quantity Affected
368 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0302-2025
Status: ongoing
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