Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary ...
FDA Device Recall #Z-0081-2014 — Class II — September 27, 2013
Recall Summary
| Recall Number | Z-0081-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 27, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cordis Corporation |
| Location | Miami Lakes, FL |
| Product Type | Devices |
| Quantity | 29,395 units |
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.
Lot / Code Information
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 15843764 15495653 15820539 15353473 15495652 15647053 15848940 15506862 15845139 15358769 15501261 15652040 15855704 15525423 15854729 15366482 15501864 15656567 15857848 15543607 15860770 15370260 15505204 15659250 15863068 15375958 15513357 15667702 15870135 15380088 15518418 15670742 15875172 15385970 15522427 15675940 15878645 15386960 15526913 15683409 15884283 15386963 15529312 15690240 15896484 15389049 15530028 15694650 15918862 15391340 15535323 15698900 15925083 15396804 15538438 15704985 15932575 15400773 15544128 15707198 15932586 15406817 15546019 15736818 15950327 15408669 15551821 15742478 15961621 15409489 15556617 15747949
Other Recalls from Cordis Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0221-2022 | Class II | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ F... | Oct 1, 2021 |
| Z-0216-2022 | Class II | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
| Z-0218-2022 | Class II | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0220-2022 | Class II | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Fl... | Oct 1, 2021 |
| Z-0219-2022 | Class II | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex... | Oct 1, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.