The FDA identified a recall from Medtronic

(NYSE: MDT)
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Class I nerve monitoring systems, the most serious type of recall.

This recall is about repairing the devices, not removing them from the market. The device can cause serious injury or death if continued use without repair, the FDA says.

Medtronic’s correction includes the NIM vital nerve monitoring system. This intraoperative nerve monitoring system allows physicians to identify, confirm and monitor nerve function, helping to reduce the risk of nerve damage during head and neck surgery.

The system helps locate, monitor and stimulate cranial and spinal nerves, as well as peripheral motor and mixed motor-sensory nerves. It emits an EMG tone when the probe is placed on a nerve, helping to prevent nerve damage.

Medtronic received FDA approval for the system in 2020.

The medical device giant issued its correction in response to reports of false negative reactions. These can occur during procedures. In these cases, the device may not emit an EMG tone. According to Medtronic, the use of affected products can have serious health consequences. These can include nerve damage, facial nerve damage, nerve weakening (paresis) and nerve paralysis.

Medtronic received reports of 10 injuries and no reports of deaths. The company is providing a new software version (1.5.4) to correct the problem. A Medtronic representative will contact each organization to install software version 1.5.4, which corrects the problem.