Reported Apr 1, 2020 · Terminated
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Micro Therapeutics Inc., dba Ev3 Neurovascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro Therapeutics Inc, Dba Ev3 Neurovascular · 9775 Toledo Way · Irvine, CA · 92618-1811
Is this the product you have?
- ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
- Lot codes and dates
- Lots
323 of 323 codes
A918616A918617A918618A918619A918620A918621A918622A918623A918624A918625A918626A918628A918665A918667A918668A920902A922597A922598A922599A922600A922601A922687A922688A922690A922691A922692A922693A922694A922695A922697A922698A922699A925289A925290A925291A925292A925293A925295A925296A925297A925298A925299A925300A925913A925914A925915A925917A925918A925920A925923A925926A925928A925929A925930A925931A926530A926531A926532A926533A926536
- Lots
- Amount recalled
- 762
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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