BEUDAMED
    FDA Recall Terminated

    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

    Recall: Z-1453-2014 · Initiated April 1, 2014

    Recall

    Recall Number
    Z-1453-2014
    Event Number
    67893
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 1, 2014
    Posted
    April 16, 2014
    Terminated
    October 31, 2014
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

    Reason

    Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

    Action

    A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at [email protected].

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

    Quantity

    32 units total (23 units in US)