SynchroMed II Infusion Pumps Recalled by Medtronic Over Battery DefectSep 13, 2011 | Parker Waichman LLP
Medtronic Inc.’s Model 837 SynchroMed II Infusion pumps have been named in a Class I recall, according to the U.S. Food & Drug Administration (FDA). The affected SynchroMed II Infusion pumps could suffer from reduced battery function, leading to the sudden loss of therapy and the return of underlying symptoms and/or withdrawal symptoms.
This recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011. The pumps involved in this recall are indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. They are also indicated for delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer, the FDA said.
According to the agency, Medtronic’s analysis of the battery problem indicates it is related to the formation of a film within the pump battery. The company is encouraging patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm. Medtronic is not recommending that patients with the recalled pumps implanted have them removed due to the low occurrence rate of the battery problem, as well as the risks associated with replacement surgery.
Medtronic sent an urgent medical device correction letter to clinicians in July 2011 informing them of this problem, citing 55 confirmed cases of malfunction among some 139,653 devices implanted worldwide. A news release was also issued on July 8, 2011.
SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.
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.