A Class I recall has been issued for Medtronic's StealthStation System with StealthStation Cranial software, which is used for locating anatomical structures during neurosurgery.
Medtronic has issued the recall for devices distributed between March 21, 2017, and March 22, 2024, according to a June 5 alert from the FDA.
The StealthStation is indicated for use in any medical condition for which stereotactic surgery of the brain or spine may be appropriate and for which reference to a rigid anatomical structure, such as the skull, can be identified in relation to images of the anatomy, including tumor resections, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead and probe placements and cranial biopsies.
Medtronic is recalling the StealthStation S8 Application versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. Customers complained that a software error was causing numbers or letters to be missing from the displayed text and replaced by a space in either the "distance to target" or "tip stop point" display during navigation.
The missing number may result in the mechanical depth stop being set too short or too long, causing surgeons to use an incorrect measurement for placement of the biopsy tip stop during navigation.
Incorrect placements could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage; abnormal functions to the brain, spine, or muscles; paralysis; or death.
Medtronic has received 28 complaints related to this issue, but no reported injuries or deaths.