The FDA Dec. 17 classified Medtronic's recall of its implanted drug pumps as Class I, the most serious type of recall, according to MassDevice.
Medtronic originally recalled 11,299 of its pumps, called the SynchroMed II, in October after it received reports of some of the pumps' motors stalling due to the presence of a foreign particle in the motor.
The device is used to treat chronic, intractable pain by delivering prescription drugs through a catheter to a patient's spinal fluid.
The motors stalling in the device could cause drug withdrawal, return of symptoms of underlying conditions, the need for surgery to replace the pump or death, according to the FDA.
On Dec. 13, Medtronic issued a notification to healthcare providers, advising them not to replace potentially affected pumps due to the low number of reported issues related to the recall, the presence of pump alarms that are designed to alert of issues and the risks associated with replacement surgery.
Medtronic told MassDevice in October that the presence of a foreign particle in the motor of some pumps was due to an "isolated manufacturing issue." The company added it had identified the source of the foreign particle and eliminated it.
Medtronic also confirmed five reports of motor stall due to the presence of a foreign particle that resulted in drug withdrawal and surgery to replace the pump. No deaths were reported.
Read the full article here.