The U.S. Food and Drug Administration (FDA) has announced a Class I recall on Medtronic’s Stealthstation S8, a cranial surgery system, for a software error on Wednesday.
Class I recall is the most serious type of recall, use of these devices may cause serious injuries or death, according to the FDA. Stealthstation S8 is a cranial surgery system that aids in locating anatomical structures during neurosurgery. The recall is made on Stealthstation S8 versions 1.
2.0, 1.1.
0, 1.0.3, 1.
0.2, and 1.0.
1, affecting 876 systems, which were distributed between March 21, 2017 and March 22, 2024. Such a move could lead to serious and permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death. In its recall notice, the FDA said the StealthStation is “indicated for use in any medical condition where stereostatic surgery of the brain or spine may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified in relation to images of the anatomy.
” The cranial surgery system can be used for tumor resections, general ventricular catheter replacement, pediatric ventricular catheter placement, cranial biopsies, and placement of depth electrode probes. To date, Medtronic has reported 28 complaints related to the issue. There have been no reports of injuries or death.
Individuals affected by the recall include people who have performed or received cranial surgeries with .
