FDA Issues Class I Recall of Drug Infusion Pumps

 Posted on August 30, 2013 in FDA

The US Food and Drug Administration (FDA) recently announced a Class I recall of Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The affected products were manufactured between May 1998 and June 2013, and were distributed from April 1999 through June 2013. The pumps contain and administer prescribed drugs to a specific site inside the patient's body, and are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.

According to a recall alert issued by the agency, within these pumps are feedthroughs, acting as components that provide an electronically insulated path for current flow from the electronic circuitry to the motor. An electronic short can occur if, over time, ions from drug solution, combined with humidity, permeate the drug pathway tubing inside the pump and interact with the feedthrough.

If this happens, it can cause a motor stall or low battery reset/alarm and lead to a loss or reduction in therapy. This can result in the return of the patient's underlying symptoms and/or withdrawal symptoms. The FDA warns this could result in serious adverse health consequences, including death.

According to an urgent health correction letter Medtronic sent to physicians in May, all SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps have the potential to be affected by this medical device defect, regardless of the age of the device or the type of drugs being administrated by it.

The company cites 380 relevant product failure reports from the 181,400 pumps that have been implanted worldwide. The company does not advise preventive pump removal surgery, but warned physicians what the signs were of a failing pump, including any return of a patient's baseline symptoms. They also requested that all extracted products be returned.

If you've suffered injuries caused by a defective medical device, contact an experienced Illinois defective medical device attorney to find out what compensation you may be entitled to for pain and loss.