BEUDAMED
    FDA Recall Terminated

    Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    Recall: Z-0955-2008 · Initiated August 3, 2007

    Recall

    Recall Number
    Z-0955-2008
    Event Number
    45595
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 3, 2007
    Posted
    February 9, 2008
    Terminated
    December 27, 2011
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    Reason

    Pump Motor Stall; pumps can stall due to gear shaft wear.

    Action

    Begining August 3, 2007, consignees were notified by letter. The letter "Medtronic Urgent: Medical Device Correction Aug 2007" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.

    Distribution

    Worldwide-USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of HONG KONG, JAPAN, AUSTRALIA, CANADA, BELGIUM, CROATIA, AUSTRIA, CYPRUS, The CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN, ICELAND, IRELAND, ITALY, JORDAN, KWAIT, LEBANON, MALTA, The NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAN MARINO, SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, The UNITED KINGDOM, CHILE, VENEZUELA, BRAZIL, and MEXICO.

    Quantity

    81,023 total for recalls Z-0950-0957-2008