BEUDAMED
    FDA Recall Terminated

    Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035

    Recall: Z-0085-04 · Initiated September 24, 2003

    Recall

    Recall Number
    Z-0085-04
    Event Number
    27491
    Firm
    Concentric Medical Inc
    FEI Number
    3003271051
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2003
    Posted
    July 20, 2004
    Terminated
    December 4, 2003
    Address
    1380 Shore Bird Way, Mountain View, CA, 94043-1338

    Description

    Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035

    Reason

    The device has the potential for tip breakage during use.

    Action

    On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA. The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    97 units