BEUDAMED
    FDA Recall Terminated

    DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.

    Recall: Z-0609-2009 · Initiated September 29, 2008

    Recall

    Recall Number
    Z-0609-2009
    Event Number
    50173
    Firm
    Medtronic Cardiovascular Revascularization & Surgical Therap
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 29, 2008
    Posted
    January 26, 2009
    Terminated
    May 7, 2011
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.

    Reason

    Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.

    Action

    Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.

    Distribution

    Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.

    Quantity

    380 US ; 180 OUS