BEUDAMED
    FDA Recall Terminated

    BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

    Recall: Z-1141-03 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-1141-03
    Event Number
    26854
    Firm
    Abbott Vascular Devices
    FEI Number
    3000718335
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    August 20, 2003
    Terminated
    August 20, 2003
    Address
    400 Saginaw Drive, Redwood City, CA, 94063

    Description

    BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

    Reason

    The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.

    Action

    On 7/21/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.