BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1887-2013 · Initiated March 29, 2013

    Recall

    Recall Number
    Z-1887-2013
    Event Number
    65482
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DTK
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 29, 2013
    Posted
    August 7, 2013
    Terminated
    October 27, 2014
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    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

    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 [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.

    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

    Quantity

    33,000 units