Medtronic Drug Infusion Pump Recall

The FDA issued a recall of Medtronic’s SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps due to the potential for intermittent or permanent motor stall due to the use of unapproved drugs. As the name of the device suggests, it is implanted into the body in order to administer drug dosages directly to a certain area of the body.

The FDA further warned that unapproved formulations, unapproved concentrations or compounded drugs should not be used with these pumps. Medical professionals have been placed on notice by letter.

This is a Class I recall, which is the most serious level. Serious injury or death is a real possibility. More information can be found here and here.