Medtronic SynchroMed and IsoMed Recall

Medtronic SynchroMed EI Implantable Infusion Pumps stall at unusually high rates, according to a recall notice posted on the FDA's website, putting patients at serious risk of injury or death. The Medtronic SychroMed EI Implantable Infusion Pumps allegedly stall at a higher rate due to shaft wear. This stalling stops drug delivery without warning, and patients can experience return of their pain symptoms and drug withdrawal symptoms.

The SynchroMed pump is implanted into a patient where it is meant to administer drugs to treat pain or muscle spasticity. It can be implanted with or without a side catheter port.

The recall involves SynchroMed Infusion Pump models:
8626-10
8626L-10
8626-18
8627-10
8627L-10
8627-18, and
8627L-18 with motors manufactured before September 1999.

The Medtronic SynchroMed and IsoMed recall is now classified as a Class I recall - which means that there is a reasonable probability that use of the product will cause injury or death.

Patients may be at risk of inflammatory mass formation - a chronic inflammatory mass at or near the tip of the catheter. No deaths have been reported to date, however serious symptoms including paralysis and neurological impairments have occurred.

The risk of inflammatory mass seems to increase over time, and with higher drug doses.

Medtronic SynchroMed and IsoMed Recall Legal Help

If you or a loved one has suffered damages due to a Medtronic SynchroMed Infusion Pump failure, please click the link below to send your complaint to a lawyer who will evaluate your claim at no cost or obligation.
Published on Apr-15-08