—#46457

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.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S042
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.

Timeline

Recall initiated: 2006-06-06
Posted by FDA: 2006-10-20
Terminated: 2010-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46457. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.