Reported Apr 1, 2020 · Terminated
ev3 Pipeline Flex Embolization Device. 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. For neurological endovascular use.
- Lot codes and dates
- Lots
317 of 317 codes
A920066A920068A920069A920070A920071A920072A920073A920074A920075A920076A920078A920079A921354A921355A921356A921357A921358A921359A921360A921361A921362A921363A922016A922017A922018A922020A922021A922022A922480A922481A922483A922484A922571A922572A922575A923951A923956A923959A923960A923963A923967A923968A923969A924193A924194A924197A924198A924199A924638A924640A924641A924642A924643A924644A924645A924646A924647A924648A924650A927827
- Lots
- Amount recalled
- 1050
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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