LifeStream Balloon Expandable Vascular Covered Stent (2018-10-29)
In plain language
This recall involves the LifeStream Balloon Expandable Vascular Covered Stent sold in Canada. It's being recalled because the actual rate of restenosis (re-narrowing of the blood vessel) was higher than predicted. Healthcare professionals should update their Instructions for Use to include new clinical trial results.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
LifeStream Balloon Expandable Vascular Covered Stent
Model: LSM0800526, LSM0800537, LSM0800616, LSM0800626, LSM0800637, LSM0800658, LSM0800716, LSM0800726, LSM0800737, LSM0800758, LSM0800816, LSM0800826, LSM0800837, LSM0800858, LSM0800938, LSM0800958, LSM0801038, LSM0801058, LSM0801238, LSM0801258, LSM1350526, LSM1350537, LSM1350616, LSM1350626, LSM1350637, LSM1350658, LSM1350716, LSM1350726, LSM1350737, LSM1350758, LSM1350816, LSM1350826, LSM1350837, LSM1350858, LSM1350938, LSM1350958, LSM1351038, LSM1351058, LSM1351238, LSM1351258
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Restenosis risk
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: LSM0800526, LSM0800537, LSM0800616, LSM0800626, LSM0800637, LSM0800658, LSM0800716, LSM0800726, LSM0800737, LSM0800758, LSM0800816, LSM0800826, LSM0800837, LSM0800858, LSM0800938, LSM0800958, LSM0801038, LSM0801058, LSM0801238, LSM0801258, LSM1350526, LSM1350537, LSM1350616, LSM1350626, LSM1350637, LSM1350658, LSM1350716, LSM1350726, LSM1350737, LSM1350758, LSM1350816, LSM1350826, LSM1350837, LSM1350858, LSM1350938, LSM1350958, LSM1351038, LSM1351058, LSM1351238, LSM1351258
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?
Restenosis risk
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return, repair, or dispose of it as instructed.
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. Restenosis risk
When was this product recalled?
This product was recalled on November 15, 2018.
Is the LifeStream brand affected by this recall?
Yes, LifeStream products are affected by this recall. This recall involves the LifeStream Balloon Expandable Vascular Covered Stent sold in Canada. It's being recalled because the actual rate of restenosis (re-narrowing of the blood vessel) was higher than predicted. Healthcare professionals should update their Instructions for Use to include new clinical trial results.