FDA POSTS NOTICE OF CLASS I RECALL OF MEDTRONIC SYNCHROMED EL PROGRAMMABLE INFUSION PUMPS

The FDA posted a notice Oct. 20 to announce a Class I recall of four models of Medtronic SynchroMed EL programmable infusion pumps.

The implantable device administers drugs to a specific site in the body to treat pain, continuous muscle contraction and cancer.

The recall has been issued because the catheter access ports on pumps manufactured between March and July 1999 may detach from the main body of the pumps, which can interrupt drug flow to the target site, the FDA said. "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."

Medtronic Neurological initiated the recall June 6 in a letter to healthcare providers.

To view the notice, go to www.fda.gov/cdrh/recalls/recall-060606.html (http://www.fda.gov/cdrh/recalls/recall-060606.html).