Navigation System Recalled by Medtronic

The goal of Medtronic’s Stealthstation device is to assist surgeons in locating physiological features when doing neurosurgery.

A programme employed with Medtronic’s Stealthstation S8 system is the subject of the most recent recall. Throughout navigation, an error in the software may result in letters or digits being absent from the text that is shown and being substituted by a space.

The recall was classified by the FDA as Class I, which is the most severe category.

A Medtronic spokesperson commented: “A software update to correct this issue is in place and we are deploying it to any impacted [Stealthstation] S8 systems as quickly as possible.”

The FDA’s notification states that the return is a rectification and does not request for the device to be removed.

Due to issues with the cranial biopsy process programme no longer synchronising with different navigational data on the screen, Stealthstation was also withdrawn in 2020 and 2021.