BEUDAMED
    FDA Recall Terminated

    Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

    Recall: Z-2165-2008 · Initiated May 1, 2007

    Recall

    Recall Number
    Z-2165-2008
    Event Number
    48607
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 1, 2007
    Posted
    August 26, 2008
    Terminated
    September 10, 2008
    Address
    Scientific Place Natick, MA, 01760

    Description

    Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

    Reason

    The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

    Action

    Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.

    Distribution

    International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.

    Quantity

    24 Units