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Polarx fit short and long tip cryoablation balloon catheter
Official notice
15 Oct 2024
An official Health Canada notice concerns Polarx fit short and long tip cryoablation balloon catheter. 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 Published 2024-10-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76335
Official notice
2024-10-15
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Boston Scientific, Polarx Fit Short And Long Tip Cryoablation Balloon Catheter.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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