BEUDAMED
    FDA Enforcement Class I Terminated

    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

    Recall: Z-1454-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1454-2014
    Event ID
    67893
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    April 1, 2014
    Classification Date
    April 16, 2014
    Termination Date
    October 31, 2014
    Address
    9775 Toledo Way, N/A, Irvine, CA, 92618-1811, United States

    Description

    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

    Reason

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

    Code Info

    ARD Model/ Lot FA8881040 / 9769118 FA8881030 / 9816048 FA8881040 / 9754682 FA8881050 / 9772283 FA8881040 / 9752800 FA8881030 / 9751662 FA8881030 / 9773525 FA8881020 / 9832735 FA8881040 / 9757667 FA8881020 / 9774620 FA8881030 / 9834039 FA8881040 / 9758530 FA8881020 / 9774620 FA8881030 / 9834039 FA8881030 / 9758532 FA8881030 / 9783730 FA8881020 / 9836553 FA8881050 / 9760946 FA8881040 / 9786013 FA8881030 / 9834039 FA8881030 / 9761690 FA8881040 / 9787928 FA8881050 / 9848544 FA8881020 / 9761692 FA8881030 / 9791385 FA8881030 / 9848543 FA8881030 / 9758532 FA8881040 / 9793305 FA8881030 / 9853152 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9854769 FA8881040 / 9764206 FA8881030 / 9798648 FA8881030 / 9858153 FA8881040 / 9764212 FA8881050 / 9801041 FA8881030 / 9865759 FA8881030 / 9766949 FA8881020 / 9811215 FA8881050 / 9868025 FA8881030 / 9769117 FA8881030 / 9813908

    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

    567 units total (323 units in US)