FDA Medical Device Recalls (openFDA)
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, catheters, and catheter accessories.
- Recall number
- Z-0022-2007
- Recalling firm
- Medtronic Neuromodulation
- Product
- 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, catheters, and catheter accessories.
- Status
- Terminated
- Initiated
- 2006-06-06
- Posted
- 2006-10-20
- Terminated
- 2010-07-06
- 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.
- Lot, serial or model codes
- Model 8627-10, serial numbers: NGE000001 - NGE000242R . Model 8627-18, serial numbers: NGF000001 - NGF003266R. Model 8627L-10, serial numbers: NGG000001R - NGG000068R, Model 8627L-18, serial numbers: NGH000001R - NGH001780R.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004S042"]
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28