Class I

Medical Device Recall: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

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

4422 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0297-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Boston Scientific Corporation Medical Device Recall: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. | SafeCheck