Class I

Medical Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

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

960 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0300-2025

Status: ongoing

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