Hundreds of serious injuries and at least 14 deaths have been linked to Medtronic SynchroMed infusion pumps, mostly due to accidental drug overdoses. The FDA has also issued Class I recalls for battery and electrical problems.
Overview
Medtronic Inc. manufactures the SynchroMed EL and SynchroMed II infusion pumps for the management of chronic pain. The devices are implanted in the body and deliver a continuous flow of medications.
14 Deaths Linked to SynchroMed Pumps
In June 2013, Medtronic issued Class I recalls for four separate safety issues that led to 14 patient deaths. Eleven patients died from overdoses when drugs were injected into tissues instead of the pump.
Medtronic Stops Selling SynchroMed Pump
In April 2015, after years of ongoing safety problems, Medtronic told the Justice Department and FDA it would stop selling SynchroMed pumps without admitting any wrongdoing.
SynchroMed Overdose Injuries and Deaths
Medtronic recalled SynchroMed pumps in January 2011 due to the risk of deadly overdoses when doctors injected painkillers directly into the patient when trying to refill the pump.
The FDA received 270 reports of serious injuries and 8 deaths associated with the problem. In July 2012, the FDA issued a warning after finding that Medtronic knew about the issue in 2007 and did not fix it.
Recalls Issued for Short-Circuiting and Battery Issues
SynchroMed II infusion pumps were recalled in 2009 and 2011 for battery problems that could stop infusion of medicines. The SynchroMed II and EL were both recalled in June 2013 for electrical short-circuiting problems.
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