BEUDAMED
    FDA Recall Terminated

    The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device.

    Recall: Z-0811-05 · Initiated April 12, 2005

    Recall

    Recall Number
    Z-0811-05
    Event Number
    31819
    Firm
    Heartport, Inc. Route
    FEI Number
    3000719637
    Product Code
    DWZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2005
    Posted
    May 10, 2005
    Terminated
    October 31, 2005
    Address
    22 West, Somerville, NJ, 08876

    Description

    The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device.

    Reason

    Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.

    Action

    The recall was initiated on 4/8/2005. All accounts were phoned so as to cancel any scheduled surgical procedures that rely on these devices. Also the firm formally notified the hospitals in writing via letters to the Director of Material Managment, Director of OR, as well as the Director of the Cardiovascular Suite. Letters were sent via certified mail.

    Distribution

    The devices were distributed to 70 consignees in the US and 43 international customers. The devices are distributed directly to customers (hospitals, clinics) in the US, Belgium, Canada, Czech Republic, France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, and Spain. There are no government accounts.

    Quantity

    1029 units