BEUDAMED
    FDA Recall Terminated

    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

    Recall: Z-0032-04 · Initiated August 20, 2003

    Recall

    Recall Number
    Z-0032-04
    Event Number
    27231
    FEI Number
    3002095335
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2003
    Posted
    October 15, 2003
    Terminated
    October 24, 2005
    Address
    Boston Scientific Scimed One Scimed Place Maple, Grove, MN, 55311-1566

    Description

    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

    Reason

    Some of the recalled catheters have a component that has levels of pyrogens above specification.

    Action

    Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.

    Distribution

    The recalled products were distributed to consignees located nationwide in the United States.

    Quantity

    2 catheters