Reported Nov 16, 2016 · Terminated
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01…
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?
- X-Celerator Hydrophilic Exchange Guidewire Catalog No.
103-0601-300103-0601-350V10103-0602-350V06103-0601-300V01103-0602-300103-0602-350V09103-0601-300V02103-0602-300V01103-0602-350V10103-0601-300V03103-0602-300V02103-0601-300V06103-0602-300v06103-0601-300V10103-0602-300V09103-0601-300V11103-0602-300V10103-0601-350103-0602-350103-0601-350V01103-0602-350V01103-0601-350V06103-0602-350V02
- Lot codes and dates
210 of 210 codes
953084997096039797735A002136A043280A123449A183571953085197433249802698A002460A043281A123450A185838953188297433289802700A002610A043969A123452A185841956773297463999848318A004560A044251A134837A194324958521197464039882269A004561A044252A136164A194327958524797506149931088A005008A097470A136165A195347958524997506159931089A005011A097472A142394A200386958528297506189931093A005477A097473A142395A200387958528397506199979485A005478
- Amount recalled
- 10,516 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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