Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

FDA Recall Z-0300-2025 · Posted 2024-11-12

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeOAE
Date Initiated2024-10-10
Product Quantity960 units

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.

Firm Action

Boston Scientific disseminated a letter to Physicians/Healthcare Professionals on 10/10/2024 via courier. The letter notified its consignees of updates to the instructions for use (IFU) for the POLARx and POLARx FIT Cryoablation Catheter related to the risk of atrioesophageal (AE) fistula. The firm requested that the information be shared with clinicians who use the use the Boston Scientific POLARx Cryoablation System, including the POLARx Catheter, the POLARx FIT Catheter and the SMARTFREEZE Console, and to share the communication with any other organization to which these devices may have been transferred. Users were directed to immediately post the information on or near the product to ensure this information is easily accessible to all users of the device.

Root Cause

Device Design

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑