Reported Sep 3, 2014 · Terminated
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is…
Cook Inc.
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: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.
- Lot codes and dates
- Model Number(s)VRS-6.0-9.0
- Lot numbers
35834163583418358342235834243583426358342835834303583432358343435834363583440358344235834523583456358345835834623583464358346635834683583470358347235834743583476358347835834803583482358348435834863583488358349035834923583494358349635834983583500358350235835044293921429392342939254293927431957343195754319577431957943195814319583431958543195874319589431959145723653583418X3583430X3583442X3583442XX3583464XXX3583480XXand 3583486X
- Amount recalled
- 696 devices total distribution (671 nationwide)
Where it was sold
Why it was recalled
Stop using this product now
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
Using this product could cause serious injury, illness or death — stop using it now.
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