Medtronic PLC is recalling its implantable drug pump called Medtronic SynchroMed II due to reports of permanent motor stall caused by the presence of foreign particles.
Medtronic SynchroMed II implantable pump is part of Medtronic's SynchroMed Infusion System that ensures the controlled delivery of drugs into a patient's body.
The Dublin based company recalled 7,317 devices in the U.S. that were distributed between May 11, 2018, and Sept. 5, 2019, and confirmed five cases in which the motor stalled. Medtronic added that another pump, which was removed because of infection, also contained a foreign particle but there were no signs of a motor stall. No deaths have been reported due to this issue.
The U.S. Food and Drug Administration gave the recall the Class I label, its most serious designation for defective products that can cause serious health problems or death.
The Irish healthcare equipment manufacturer initially informed hospital risk managers and distributors about the affected models in October. The company also gave instructions regarding identifying and returning any affected unused product.
Medtronic recommends against preventive replacement of the pumps citing low occurrence of motor stalls from this issue, presence of pump alarms and the risk linked with the replacement surgery.
The company asked healthcare providers to inform patients and caregivers of symptoms that could occur from a motor stall along with asking them to be attentive to all alarms, seek immediate medical attention in case of drug withdrawal or noticeable signs of their underlying condition, and follow instructions if they receive an alert message in the application.