BEUDAMED
    FDA Recall Terminated

    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.

    Recall: Z-2218-2010 · Initiated December 4, 2009

    Recall

    Recall Number
    Z-2218-2010
    Event Number
    54687
    Firm
    AngioScore Inc.
    FEI Number
    3005462046
    Product Code
    NWX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 4, 2009
    Posted
    August 18, 2010
    Terminated
    June 21, 2011
    Address
    5055 Brandin Ct, Fremont, CA, 94538-3140

    Description

    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.

    Reason

    Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.

    Action

    AngioScore sent an "Urgent: Medical Device Voluntary Recall" dated December 4, 2009 addressed to "Catheterization Lab Manager" at consignees. The Recall notification letter instructed consignees to inspect their inventory to detect product from the involved lot, and segregate it from their inventory. Consignees were asked to record all affected product and fax return forms to the firm. AngioScore Customer Service will contact consignees and provide instructions for return and replacement of affected product.. Consignees can contact AngioScore at 877-264-4692.

    Distribution

    Nationwide distribution.

    Quantity

    3870 units