Events

Recall of Device Recall OptEase Vena Cava Filter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65482
  • Event Risk Class
    Class 1
  • Event Number
    Z-1887-2013
  • Event Initiated Date
    2013-03-29
  • Event Date Posted
    2013-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119066
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filter, intravascular, cardiovascular - Product Code DTK
  • Reason
    Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
  • 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 MiamiQA@crdus.jnj.com. 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.

Device

Device Recall OptEase Vena Cava Filter
  • Model / Serial
    Model Numbers 466F220A and 466F220B.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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 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.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA