Recall Z-0951-2008 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed EL Programmable Pumps, Model 8626L-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)
| Date | Feb 9, 2008 (initiated Aug 3, 2007) |
| Status | Terminated |
| Reason | Pump Motor Stall; pumps can stall due to gear shaft wear. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.