Class 1 Recall: Medtronic SynchroMed EL Programmable Infusion Pumps

Date Recall
Initiated:

June 6, 2006

Product:

Medtronic SynchroMed EL Programmable Infusion Pumps
Models 8627-10, 8627-18, 8627L-10, 8627L-18

Use:

This device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.

Recalling Firm:

Medtronic Neurological
800 53rd Ave NE
PO Box 1250
Minneapolis, MN 55440-1250

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. If the drug flow is interrupted, the patient may experience loss of therapy, return of underlying symptoms, and/or symptoms of drug withdrawal, which can be fatal.

Public Contact:

Medtronic Neurological Patient Services: 1-800-510-6735
Medtronic Neurological Technical Services: 1-800-707-0933

FDA District:

Minneapolis

Advice to Users

• Medtronic sent an Urgent Medical Device Recall letter to healthcare providers beginning June 06, 2006. The letter describes the issue and patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks healthcare providers to return a response card to Medtronic.
• Explanted devices should be returned to Medtronic through the Medtronic Representative.
• FDA has determined that this is a Class I recalls, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.