December 16, 2019

FDA: Medtronic recalls SynchroMed II implantable drug infusion pump

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump.

The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall.

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Medtronic has confirmed five reports of motor stall, which resulted in drug withdrawal, surgery to replace the pump, and delay of care. A sixth pump was removed surgically because of an unrelated infection and found to contain a foreign particle. No deaths have been reported.

Model numbers of the affected pumps are 8637-20 and 8637-40. Distribution dates were May 11, 2018 to September 5, 2019.


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