FDA Device recall Z-0081-2014
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in t…
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in t… by Cordis, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0081-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-27 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cordis |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | 15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15…15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533 15793939 15381573 15652041 15307999 15454044 15598216 15799364 15402503 15670744 15312441 15456163 15605008 15802178 15406808 15686286 15317387 15460104 15606053 15809353 15430934 15699350 15320551 15466748 15610330 15812239 15435039 15737306 15325507 15471008 15614689 15816462 15444313 15762046 15330287 15473247 15627966 15822489 15462543 15768649 15335203 15478342 15632159 15830469 15466749 15793940 15340786 15480569 15632931 15836564 15473249 15798681 15344590 15487383 15637332 15839559 15481997 15814435 15350806 15490348 15643482 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2014%22
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