Date Recall |
June 6, 2006 |
Product: |
Medtronic SynchroMed EL Programmable Infusion Pumps |
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 |
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 |
FDA District: |
Minneapolis |
Advice to Users |
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Updated October 20, 2006
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