BEUDAMED
    FDA Recall Terminated

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020.

    Recall: Z-0841-2011 · Initiated November 16, 2010

    Recall

    Recall Number
    Z-0841-2011
    Event Number
    57271
    Firm
    AngioScore Inc.
    FEI Number
    3005462046
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2010
    Posted
    January 4, 2011
    Terminated
    October 4, 2011
    Address
    5055 Brandin Ct, Fremont, CA, 94538-3140

    Description

    AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020.

    Reason

    Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.

    Action

    Medical Device Recall notifications were sent to all domestic consignees on Nov 16, 2010 by overnight mail. Foreign distributors, other than Japan, were sent recall letters by e-mail or international overnight delivery on November 16, 2010. The Japanese distributor received notification and notified their customers on November 10, 2010.

    Distribution

    Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom

    Quantity

    17682 units, all sizes and lots