BEUDAMED
    FDA Recall Terminated

    TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.

    Recall: Z-1305-06 · Initiated April 6, 2006

    Recall

    Recall Number
    Z-1305-06
    Event Number
    35280
    Firm
    Kensey Nash Corp
    FEI Number
    1000307073
    Product Code
    NFA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2006
    Posted
    July 28, 2006
    Terminated
    August 10, 2006
    Address
    735 Pennsylvania Dr, Exton, PA, 19341-1130

    Description

    TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.

    Reason

    Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting

    Action

    The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.

    Distribution

    The product was shipped to hospitals in Germany and Italy.

    Quantity

    69 kits