Product Wiki · Recalls · Health Canada — Medical Devices

Polarx FIT Short and Long Tip Cryoablation Balloon Catheter — recall 76335

Health Canada — Medical Devices · Canada · 2024-10-15 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
76335
Date of alert
2024-10-15
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Cardiovascular - Anaesthesiology
Product type
Medical devices
Reported risk: Boston Scientific is initiating an advisory to provide updates to the POLARx™ and POLARx™ FIT Cryoablation Catheter Instructions For Use (IFUs) related to the risk of atrio-esophageal fistula (AEF). Recall Start Date: October 10, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/polarx-fit-short-and-long-tip-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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