The FDA identified a recall of Medtronic (NYSE: MDT) + nerve monitoring systems as Class I, the most serious kind of recall.

This recall involves correcting devices, not removing them from the market. The device may cause serious injury or death if people continue using it without correction, the FDA says.

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

The system helps locate, monitor and stimulate the nerves of the skull and spine, plus peripheral motor and mixed motor-sensory nerves. It issues an EMG tone during probe placement on a nerve, helping to prevent nerve damage.

Medtronic received FDA clearance for the system in 2020.

The medtech giant issued its correction in response to reports of false negative responses. These can occur during procedures. In these cases, the device may fail to issue an EMG tone. Using affected products may cause serious adverse health consequences, according to Medtronic. These can include nerve damage, facial nerve damage, nerve weakening (paresis), and nerve paralysis.

Medtronic received reports of 10 injuries and no reports of death. The company is deploying a new software version (1.5.4) to fix the issue. A Medtronic representative will contact each organization to install software version 1.5.4, which corrects the issue.