Recall Class: Class I

Date Recall Initiated: March 29, 2013

Product(s): Optease Retrievable Vena Cava Filter

This recall covers 33,000 units distributed in the United States between 05/06/2010 and 04/02/2013.

Use: The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.

Recalling Firm:
Cordis Corporation
14201 NW 60th Ave
Miami Lakes, Florida, 33014

Reason for Recall: Labeling correction to provide clarification and additional information to minimize likelihood of implanting the filter backwards.

Public Contact:
Cordis Endovascular Medical Information Center
Monday – Friday 9:00AM – 5:00PM (Eastern Standard Time)
Phone: 1-877-338-4235
Fax: (908) 927-5133 or by e-mail to cordis_endo@crdus.jnj.com

FDA District: Florida

FDA Comments:
On 4/3/2013, Cordis Corporation sent an “URGENT Medical Device Correction” letter to their customers in the U.S. and Canada. Customers were instructed to read the description and recommendations sections of the Instructions for Use then sign and return an Acknowledgement Form directly to Cordis to their Fax number (908) 429-8287 or Scan and e-mail to MiamiQA@crdus.jnj.com. The company is also making corrections and improvements to the device labeling. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.