Recall Z-0022-2007 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. 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. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheter
| Date | Oct 20, 2006 (initiated Jun 6, 2006) |
| Status | Terminated |
| Reason | The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site. |
| Root cause | Process design |
| Action | An Urgent medical Device Recall letter was sent to healthcare providers beginning June 06, 2006. The letter describes the issue, patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks for a response card to be returned to Medtronic. Patients may contact Medtronic Neurological Patient Services at 1-800-510-6735. |
| Quantity | 4,317 pumps |
| Distribution | Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.