FDA Announces Update on Medtronic’s Infusion Pump Recall
Medtronic issued more information on its recall of approximately 7,300 SynchroMed II implantable drug infusion pumps in the U.S.
The device giant pulled the devices in October over reports of early permanent motor stalling caused by foreign particles. The issue could prevent the infusion of drugs to the patient and lead to serious repercussions, including surgery or death.
The company told healthcare providers it does not recommend prophylactic replacement of potentially affected pumps “due to the low observed occurrence of motor stall, the presence of pump alarms, and the risks associated with replacement surgery,” the agency said.