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U.S. Department of Health and Human Services

Class 1 Device Recall Boston Scientific POLARx

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 Class 1 Device Recall Boston Scientific POLARxsee related information
Date Initiated by FirmOctober 10, 2024
Date PostedNovember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0301-2025
Recall Event ID 95514
PMA NumberP220032 
Product Classification Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
ProductBoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Code Information GTIN00191506016456
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactRenee Archie
508-683-4523
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionBoston 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.
Quantity in Commerce2751 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OAE
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