Polarx FIT Cryoablation Catheter recall in Canada: labelling issue
In plain language
This recall involves Polarx FIT Short and Long Tip Cryoablation Balloon Catheters sold in Canada. It's being recalled because of updated instructions for use related to a risk of atrio-esophageal fistula (AEF). Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact Boston Scientific Corporation for additional information.
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Affected products
Polarx FIT Short Tip Cryoablation Balloon Catheter
Model: M004CRBS2010, M004CRBS2060
Lot: All lots
Polarx FIT Long Tip Cryoablation Balloon Catheter
Model: M004CRBS2110
Lot: All lots
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: M004CRBS2010, M004CRBS2060, M004CRBS2110
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves Polarx FIT Short and Long Tip Cryoablation Balloon Catheters sold in Canada. It's being recalled because of updated instructions for use related to a risk of atrio-esophageal fistula (AEF). Healthcare professionals should contact the manufacturer for more information.
What should consumers do?
Contact Boston Scientific Corporation for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on October 15, 2024.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves Polarx FIT Short and Long Tip Cryoablation Balloon Catheters sold in Canada. It's being recalled because of updated instructions for use related to a risk of atrio-esophageal fistula (AEF). Healthcare professionals should contact the manufacturer for more information.