The FDA has classified the recall of Medtronic’s (NYSE:MDT) SynchroMed II implantable drug pumps as Class I, the most serious type of recall.
The company announced the voluntary recall in October, saying that it had received complaints about the pumps’ motors stalling permanently. Permanent motor stall could prevent the infusion of drugs to the patient, which could cause serious injury, such as drug withdrawal, the return of symptoms of underlying conditions, the need for surgery to replace the pump, or death, according to the FDA.
The pumps are used to treat chronic, intractable pain, delivering prescription drugs through a catheter to the patient’s spinal fluid. The recall covers 11,299 SynchroMed II Models 8637-20 and 8637-40 manufactured between May 4, 2018, and April 5, 2019, including 7,317 pumps sold in the U.S.
A company investigation determined the presence of a foreign particle inside the motor assembly “due to an isolated manufacturing issue,” Medtronic told MassDevice in October. The company also said it had identified the source of the foreign particle and eliminated it. The company said it made its most recent advisory to physicians to reinforce the instructions it issued in October.
Last week, Medtronic confirmed five reports of foreign particle-induced motor stall that which resulted in drug withdrawal, surgery to replace the pump and delay of care, according to the FDA. A sixth pump, which was removed surgically due to an unrelated infection, was later found to contain a foreign particle, but there was no indication of a motor stall, according to the FDA. No deaths were reported.
The company last week also told healthcare providers last week that it does not recommend prophylactic replacement of potentially affected pumps because of the small number of reported motor stalls from this issue, the presence of pump alarms and the risks associated with replacement surgery. Medtronic did advise providers to discuss the signs and symptoms of motor fail with patients and caregivers.
Medtronic has provided healthcare providers with a list of patients who have been implanted with a potentially affected pump, the FDA said. The recall affects
A. A total of 11,299 SynchroMedTM II pumps manufactured from May 2018 to April 2019 could be potentially affected by the presence of a foreign particle in the pump motor assembly. Of these, 3,702 were distributed to customers outside the U.S. and are in scope of this field action.