BEUDAMED
    FDA Recall Terminated

    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

    Recall: Z-2045-2013 · Initiated July 19, 2013

    Recall

    Recall Number
    Z-2045-2013
    Event Number
    65810
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    OUT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 19, 2013
    Posted
    August 23, 2013
    Terminated
    October 17, 2013
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

    Reason

    Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "

    Action

    Covidien sent an Customer Notification letter dated July 19, 2013, to all affected customers who received affected lots of Pipeline Embolization Device (PED). The customer notification letter informed the customers of the problems identified and the actions to be taken. Customer are instructed to reply and fax response form to Covidien Customer Service at (763) 398-7001. Customers are instructed that Customer Service will issue an RGA number for the return of the affected product back to Covidien. Customers are also instructed that upon receipt of a Returned Goods Authorization (RGA) number, to write the RGA number on the FEDEX slip and send the product back to: Covidien Attention: Product Recall 14005 13th Ave Plymouth, MN 55441 Prepaid and preaddressed FEDEX slips are enclosed for their convenience. Once Covidien receives the returned units, product replacement units will be shipped directly to customers. Local Covidien Neurovascular representative is also available to assist them in expediting the exchange of product. Customers with any questions, are instructed to call (949) 839-3700.

    Distribution

    US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.

    Quantity

    62 units