Reported Nov 16, 2016 · Terminated
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22…
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?
34 of 34 products
| Model / number | Product as published |
|---|---|
FA-71350-25V16 | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 |
FA-71350-25V17 | FA-71300-25V12 |
FA-71350-25V18 | FA-71300-25V13 |
FA-71350-25V19 | FA-71300-25V15 |
FA-71350-30V09 | FA-71300-25V16 |
FA-71350-30V10 | FA-71300-25V17 |
FA-71350-30V12 | FA-71300-25V18 |
FA-71350-30V13 | FA-71300-25V19 |
FA-71350-30V15 | FA-71300-30V09 |
FA-71350-30V16 | FA-71300-30V12 |
FA-71350-30V18 | FA-71300-30V13 |
FA-71350-35V09 | FA-71300-30V15 |
FA-71350-35V10 | FA-71300-30V16 |
FA-71350-35V12 | FA-71300-30V19 |
FA-71350-35V13 | FA-71300-35V09 |
FA-71350-35V15 | FA-71300-35V12 |
FA-71350-35V18 | FA-71300-35V13 |
FA-71375-25V09 | FA-71300-35V15 |
FA-71375-25V10 | FA-71325-25V09 |
FA-71375-25V11 | FA-71325-25V10 |
- Lot codes and dates
- Additional Lots
1,603 of 1,603 codes
A010308A020911A026317A032375A036898A043417A046146A053154A010309A020912A026319A032378A036899A043663A047160A053878A010310A020913A026835A032381A036900A043667A047161A053881A010312A020914A026836A032383A036901A043668A047162A053882A010314A020916A026842A033000A036904A043911A047808A053993A010316A021047A026843A033001A036905A043912A047809A053994A013030A021410A026939A033237A036906A043913A047810A054421A013031A021411A026940A033238
274 of 274 codes
A000433A012314A017636A026690A031793A0331829938393993769999376969944949994285699361729936899994285599449469936171993839699532419952967994153199716519972525997250999785629974928997492999793499969504997959399785619977716A001480A001481A001482A001483A001484A003371A003456A003458A004018A004019A004021A004572A004574A005069A005576A005578A005579A006535A006536A006537A007195A007197A007785A007786A007788A007789A010924A011567A011607
- Amount recalled
- 11,860 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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