Medtronic and the FDA have announced a Class I recall of the SynchroMed II Infusion system. This recall includes models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
The Infusion pumps are designed to contain and administer prescribed drugs to a specific site of the body, drugs such as morphine sulfate, ziconotide and baclofen, which are used for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. The pumps are also indicated for delivery of floxuridine and methotrexate, for the treatment of primary or metastatic cancer.
This recall relates to the formation of a film within the pump battery. It has been determined that this problem can lead to the sudden loss of therapy, and the return of the underlying symptoms and/or therapy withdrawal symptoms. The FDA only issues Class I recalls when there is a reasonable probability that the use of a defective medical device will cause serious injury or death.
Medtronic pumps were the subject of a Class I recall previously in August 2007. At that time, it was Medtronic’s implantable infusion pumps that were the subject of the recall. It was determined that these pumps were stalling at an unusually high rate, putting patients at risk of serious injury or even death.
Medtronic has encouraged patients to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.