Injuries trigger Medtronic to recall its nerve monitoring system.

Medtronic initiated recalling a nerve monitoring system linked to 10 reported injuries. Although the devices remain on the market, Medtronic has cautioned that the system may fail to produce a tone when placed on a nerve, potentially leading to nerve damage.

Medtronic is addressing the issue with a software update and advises surgeons to use alternative methods and rely on their skills and anatomical knowledge if the nerve monitoring system is compromised. The NIM system, used to locate, monitor, and stimulate nerves during surgery, is designed to emit an electromyography tone to help prevent nerve damage.

In June, Medtronic issued an urgent notice after discovering that some systems failed to emit a tone when placed on a nerve. Between April 2020 and late May, the company received 70 reports of such issues, including 10 serious cases of nerve damage, facial nerve damage, and nerve paralysis. The FDA classified this recall as Class I due to the serious injury risk.

Medtronic’s investigation identified that system faults could cause false negatives by interacting with auto threshold and wireless muting functions. The company has made corrective changes and released version 1.5.4 of the NIM software to address the problem. Users will be contacted to install the update. In the interim, the FDA recommends following existing medical protocols for patients being monitored.