Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic Synch
FDA device recall Z-0022-2007 · posted 2006-10-20 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 4,317 pumps
- Distribution
- Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.
- Date initiated
- 2006-06-06
- Date posted
- 2006-10-20
- Date terminated
- 2010-07-06
- Location
- Minneapolis, MN
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