—#68047

Product

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)

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: See codes for all models in associated Recall Z-0950-2008

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-08-03
Posted by FDA: 2008-02-09
Terminated: 2011-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68047. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.