Medtronic ($MDT) has sent a letter to customers warning that use of unapproved drugs with its SynchroMed pumps can more than double the rate of device failure, and the FDA has labeled the correction a Class I due to the risk of injury and death.
The SynchroMed II and SynchroMed EL infusion pumps are designed to administer certain drugs to patients, but many physicians use them to deliver other treatments, and Medtronic says the 78-month failure rate for the devices jumps from 2.4% with approved drugs to 7% with others.
When the devices malfunction and fail to deliver their drugs, patients may experience serious adverse events, including fatality. The FDA has assigned its most serious designation to the action, asking customers to report any adverse events through its MedWatch program.
Medtronic sent its letter in November, saying that unapproved drugs exacerbate the rate of motor corrosion in the pumps and promising to investigate the root causes of the issue.