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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic SynchroMed EL

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  Class 2 Device Recall Medtronic SynchroMed EL see related information
Date Initiated by Firm August 03, 2007
Date Posted February 09, 2008
Recall Status1 Terminated 3 on December 27, 2011
Recall Number Z-0952-2008
Recall Event ID 45595
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, 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)
Code Information See codes for all models in associated Recall Z-0950-2008
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Pump Motor Stall; pumps can stall due to gear shaft wear.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 81,023 total for recalls Z-0950-0957-2008
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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