Z-0956-2008

Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway...

Name: Z-0956-2008 Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway...
Creator: Medtronic Neuromodulation
Published: 2007-08-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2007-08-03 / Terminated / root cause: design

FDA source

Medtronic Neuromodulation began a recall of Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic... on 2007-08-03. The reason FDA records is "Pump Motor Stall; pumps can stall due to gear shaft wear". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0956-2008
Status: Terminated
Initiated: 2007-08-03
Posted: 2008-02-09
Terminated: 2011-12-27
Recalling firm: Medtronic Neuromodulation
Product: Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, 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)
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Pump Motor Stall; pumps can stall due to gear shaft wear.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: See codes for all models in associated Recall Z-0950-2008

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)