FDA Anounces Class 1 Recall of Infusion Pump

Greg Owen

Attorney

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The most serious type of FDA recall is known as a "Class I recall." This type of recall is only issued if a given defective medical device will cause serious injury or death. According to the FDA recall notice, Medtronic notified its customers of the SynchroMed El Implantable Infusion Pump via a letter dated August 3, 2007.

The Implantable Infusion Pump administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The Infusion Pump recall involved models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. Only those models with motors manufactured before September 1999 are affected by the recall.

According to the FDA the pump can stop suddenly. The problem is, withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient's spine) can cause death if not treated immediately and effectively. Consumers with questions about the Medtronic SynchroMed El Implantable Infusion Pump recall can contact Medtronic Neuromodulation Patient Services at 1-800-510-6735.

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