Solarice Rapid Exchange Balloon Dilation Catheter (2019-09-04)
In plain language
This recall involves the Solarice Rapid Exchange Balloon Dilation Catheter sold in Canada. It's being recalled because a stylette removal difficulty could damage the catheter, leading to inflation/deflation problems. This could result in prolonged procedure time, additional intervention, or vessel injury during use. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Medtronic Inc. for more information.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Vessel injury risk
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Vessel injury risk
What should consumers do?
Stop using the product immediately. Contact Medtronic Inc. for more 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?
Yes, there may be a health risk. Vessel injury risk
When was this product recalled?
This product was recalled on October 3, 2019.
Is the Solarice brand affected by this recall?
Yes, Solarice products are affected by this recall. This recall involves the Solarice Rapid Exchange Balloon Dilation Catheter sold in Canada. It's being recalled because a stylette removal difficulty could damage the catheter, leading to inflation/deflation problems. This could result in prolonged procedure time, additional intervention, or vessel injury during use. Stop using the product and follow the return/repair steps in the official notice.