FDA announces recall of Medtronic brain surgery support systems
Medtronic has issued a recall on several versions of its StealthStation S8 after complaints about a software error that caused numbers not to appear on the system display. The StealthStation is used to support surgeries of the head and spine, such as catheter placements, tumor extractions and biopsies. Important numbers such as “distance to target” will not display, putting patients at risk.
While there have been no reported injuries, given the serious risk of paralysis or death associated with the malfunction, the U.S. Food and Drug Administration (FDA) has given the recall a Class I designation, denoting the most serious type of recall.
The recall was first announced by Medtronic in April.
What is being recalled?
A total of 876 StealthStation S8 Applications have been recalled, all of which were distributed to surgeons between March 21, 2017, and March 22, 2024. Medtronic said it received 28 complaints associated with versions 1.2.0, 1.1.0, 1.0.3, 1.0.2 and 1.0.1 of the StealthStation’s software, which spurred the company to recall the systems.
Medtronic sent a letter to impacted customers stating it will work to coordinate a software update at no charge to resolve the error.
Next steps
The systems need to be upgraded to the new software. Medtronic asks providers to please share the recall notice to ensure users are aware of the malfunction and get the upgrade.
After completing the system upgrade, the company asks providers to submit a customer confirmation form to neuro.quality@medtronic.com to help Medtronic to remove the older applications from service.
Providers are then advised to save a confirmation of the StealthStation S8 application upgrade for their records.
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