FDA orders class 1 recall on Medtronic drug pumpby Bill Catlin, Minnesota Public Radio
St. Paul, Minn. — The Food and Drug Administration has labeled a problem with a Medtronic drug pump a class 1 recall, the most serious type of recall. It means there is a reasonable probability that the product will cause serious adverse health consequences or death.
The pump is primarily used to treat severe pain and muscle spasticity.
In July, Medtronic warned patients that SynchroMed II Implantable drug pumps can lose battery power and fail in rare instances. Medtronic does not recommend replacing the pumps on a precautionary basis.
Last July, the Fridley-based company said that all the reported problems involved batteries manufactured before March 2005. The company is working with U.S. regulators on a new battery design to prevent the problem.
In February, the company said eight deaths had been reported in connection to mistakes in refilling the infusion pumps.
The devices are about the size of hockey puck and are implanted in the abdomen. A tube guides medication to a patient's spine.
Related: FDA medical devise recall page