Reported Nov 16, 2016 · Terminated
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body…
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?
- Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No.
FA-88810-20V04FA-88810-20V06FA-88810-30V04FA-88810-30V06FA-88810-40V04FA-88810-40V06FA-88810-50V04FA-88810-50V06
- Lot codes and dates
- Additional Lots
171 of 171 codes
99480779972887A010848A053541A116064A13103699483969972889A011322A053542A117476A13204499525129972890A011359A053543A118368A15432399573299974418A013554A053763A120498A15432499573369976051A013556A053764A122265A15658099573429976060A014832A053766A123213A15658199449659977018A014868A066445A124445A16131799452809977019A014953A066446A125283A16131899518769977396A016804A068660A132937A16389599542739977397A018473A068664A134257A163896
9973587A003969A003985A004024A004819A004964A004983A005025A005630A005730A006093A006966A007043A008142A008144A011434
- Amount recalled
- 3,337 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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