Medtronic Has Serious StealthStation S8 Recall Over Software Error

Medtronic’s recall of certain versions of its StealthStation S8 application has been tagged as Class I, the most serious type of recall, by the U.S. Food and Drug Administration (FDA). The company advised it’s a correction, not a product removal.
 
The company recalled StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after receiving complaints about a software error that caused numbers or letters to be missing from the displayed text. They are replaced by a space in either the “distance to target” or “tip stop point” display during navigation.
 
The missing digit can result in mechanical depth stop being set too short or too long. This may cause the surgeon to use an incorrect measurement for biopsy tip stop placement during navigation. Using incorrect placement in a cranial procedure can lead to brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.
 
Medtronic has reported 28 complaints concerning the issue, with no injuries or deaths.
 
The company’s April 10, 2024 Urgent Medical Device Correction letter said it will coordinate a software update free of charge to resolve the issue. Medtronic also advised reviewing the correction with all physician users and complete an enclosed confirmation form to verify the notification has been communicated to all physician users.
 
The notice should also be passed on to those who must be aware in the organization, or any organization where possible affected devices were transferred. A copy of the notice should be maintained in facility records, as well.
 
StealthStation S8 application versions 2.0 and 2.0.1 were subject to a Class I recall last year due to another software glitch that can cause surgical plan data to shift location(s) after the initial test is changed.

More about StealthStation

The StealthStation System with StealthStation Cranial software is an aid to locate anatomical structures during neurosurgery (treatment of diseases or disorders of the brain and spine).
 
It’s indicated for use in any medical condition where stereotactic 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. Cranial procedures using the system and software include:

• Tumor resections
• General ventricular catheter placement
• Pediatric ventricular catheter placement
• Depth electrode, lead, and probe placement
• Cranial biopsies