Z-0022-2007

Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable...

Name: Z-0022-2007 Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable...
Creator: Medtronic Neuromodulation
Published: 2006-06-06
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2006-06-06 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of... on 2006-06-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0022-2007
Status: Terminated
Initiated: 2006-06-06
Posted: 2006-10-20
Terminated: 2010-07-06
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.
Product code: LKK Pump, Infusion, Implanted, Programmable
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 4,317 pumps
Distribution: Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.
Product codes and lots: 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.

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)