Z-1887-2013Class I

Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) FilterREF Cat. No.466F220A and 466F220B***Vena Cava...

Name: Z-1887-2013 Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava...
Creator: Cordis Corporation
Published: 2013-03-29
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2013-03-29 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter... on 2013-03-29. FDA classified it as Class I and gives the reason as "Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1887-2013
Classification: Class I
Status: Terminated
Initiated: 2013-03-29
Posted: 2013-08-07
Terminated: 2014-10-27
Recalling firm: Cordis US Corp.
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.
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Cordis Corporation sent an "URGENT Medical Device Correction" notification to their consignees in the US by letter dated April 3, 2013 and an e-mail was sent to the Canadian consignees. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to read the description and recommendations sections carefully, then sign and return the enclosed Acknowledgement Form directly to Cordis to their fax number(908) 429-8287 or Scan and e-mail to [email protected]. The letter states to pass on the notice to anyone in the consignees' facilities that need to be informed. Additionally, the notification request consignees to maintain awareness of this notification until the information has been incorporated in the Cordis OPTEASE Vena Cava Filter labeling. For questions related to the issue contact Cordis Endovascular Medical Information Line 877-338-4235.
Quantity in commerce: 33,000 units
Distribution: 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
Product codes and lots: Model Numbers 466F220A and 466F220B.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1887-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1887-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-07

Product code DTK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)