Z-1887-2013 Class I Terminated
FDA device recall Z-1887-2013 was initiated by Cordis Corporation on Mar 29, 2013 and is designated Class I. Reason for recall: Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards. The recall status is terminated (terminated Oct 27, 2014). Affected quantity: 33,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Mar 29, 2013
- Termination Date
- Oct 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,000 units
Product Description
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of 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, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama
Code Information
Model Numbers 466F220A and 466F220B.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1887-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026