BEUDAMED
    FDA Recall Terminated

    Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403

    Recall: Z-0208-2007 · Initiated November 1, 2006

    Recall

    Recall Number
    Z-0208-2007
    Event Number
    36845
    Firm
    Medtronic Vascular
    FEI Number
    3003311129
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2006
    Posted
    November 22, 2006
    Terminated
    December 5, 2007
    Address
    5345 Skylane Boulevard, Santa Rosa, CA, 95403-1044

    Description

    Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403

    Reason

    Sterility may be compromised as evidenced by a loss of package integrity.

    Action

    On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

    Distribution

    Worldwide, including USA, Switzerland, France, Belgium, Germany.

    Quantity

    502