Cordis OPTEASE Retrieval Inferior Vena Cava — Class I medical device recall Z-1887-2013
Terminated recall by Cordis Corporation, reported 2013-08-14, distributed nationwide. Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwa
| Recall number | Z-1887-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2013-03-29 |
| Classified | 2013-08-07 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 33,000 units |
| Reason classes | labeling |
| Model numbers | 466F220A, 466F220B |
Product
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
Reason for recall
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.