Polarx FIT Short and Long Tip Cryoablation Balloon Catheter
Brand(s)
Last updated
Summary
Product
Polarx FIT Short and Long Tip Cryoablation Balloon Catheter
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Polarx FIT Short Tip Cryoablation Balloon Catheter |
All lots. |
M004CRBS2010 |
Polarx FIT Long Tip Cryoablation Balloon Catheter |
All lots. |
M004CRBS2110 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - Anaesthesiology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-76335
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