The recall is in response to 10 reported injuries resulting from false negative responses received while using the device. No deaths have been reported.
Affected users need to contact Medtronic to have the device’s software upgraded to the latest corrected version but do not need to return the device, according to the recall notice.
The device is used to prevent nerve damage during surgery. Using the device without correction may lead to nerve damage, weakening or paralysis.
Information on affected device model numbers and instructions for contacting Medtronic can be found in the FDA notice.
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