Medtronic Drug Pump Recalled by FDA

Initially, the FDA issued a safety alert regarding Medtronic’s implantable drug pump but now the federal agency has classifed it as a Class I recall. The Class I status means that there is a reasonable probability that use of the product will cause serious adverse health consequences including death. Thus far one death has been attributed to the implantable drug pump with 83 adverse reaction cases reported. The problem concerns improper connections between the pump and the catheter which can lead to an overdose of pain medication, withdrawal symptoms or a recurrence of symptoms if the drug isn’t administered properly due to the catheter connection problem.
The pump is used in patients suffering from spasticity related to cystic fybrosis. The affected pumps are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. According to Medtronic, approximately 25, 000 pumps have been sold since 2007.