Reported Nov 6, 2013 · Terminated
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Cordis Corporation · 14201 Nw 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the
- vena cava in the following situations- Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated
- Lot codes and dates
183 of 183 codes
152772091541436415560257157524291528730215550200152829881542176915565526157534781529114515566741152873011542488315568635157553031530738915570058152905451543026815572971157613151531163715582190152911461543511615579473157675661532550815593534152962781543794315581926157779971534321315612686153002991544431415585734157810961535569415627268153009951544846615591471157897231536956815638012153073901545017115593533157939391538157315652041153079991545404415598216157993641540250315670744
- Amount recalled
- 29,395 units
Where it was sold
Why it was recalled
Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.
This product could cause temporary or reversible health problems — stop using it.
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