FDA alerts to Medtronic’s Class I recall of StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2. and 1.0.1 due to software error

Consumers and medical professionals should be advised that a recall impacting five versions of Medtronic’s StealthStation S8 Application has been identified by the FDA as Class I, the most serious type. Officials said a software error could result in incorrect measurements during cranial surgery, which could then cause major injuries or death.

First initiated by Medtronic on April 10, 2024, the recall covers Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 of StealthStation 8 Application. In total, 876 devices that were distributed across the U.S. between March 21, 2017 and March 22, 2024, are impacted.

Designed to be help locate anatomical structures during neurosurgery, which treats “diseases or disorders of the brain and spine,” the StealthStation is implemented in cases where stereotactic surgery is practiced on the brain or spine, or in cases where “a rigid anatomical structure” (like the skull) needs to be referenced or identified “in relation to images of the anatomy.”

The StealthStation System with StealthStation Cranial software may allow for the following cranial procedures: “tumor resections; general ventricular catheter placement; pediatric ventricular catheter placement; depth electrode, lead, catheter placement; cranial biopsies.”

Officials say the StealthStation S8 Application versions listed above were recalled after Medtronic was made aware, through a number of customer complaints, that a software error was affecting the display of numbers or letters, causing numbers or letters to be missing or replaced by an empty space. These issues, which would show up during navigation in the “distance to target” or “tip stop point,” may cause the mechanical depth stop to be at a setting either too short or too long. As a result, the surgeon may inadvertently use the wrong measurement while placing the biopsy tip stop during navigation.

Consumers should be aware that an incorrect placement during a cranial procedure could have major adverse health outcomes and leave permanent injuries, “including brain, nerve, or cerebrovascular damage,” and could also lead to “abnormal functions to the brain, spine, or muscles.” Paralysis and death may also occur.

To date of the updated FDA announcement posted June 5, 2024, Medtronic has been made aware of 28 related complaints, but no injuries or deaths have been recorded.

An Urgent Medical Device Correction sent to Medtronic customers (namely surgeons who use StealthStation S8 with Software Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1., with regard to their patients, people who may undergo cranial surgery using the device along with the any of the five software versions) on April 10, 2024, outlining the following required actions:

  • Ensure that all physician users have reviewed the information about the product/software correction.
  • Ensure that the confirmation form is completed, and verify that all physicians are aware of the notification.
  • Use the email neuro.quality@medtronic.com to submit the completed Customer Confirmation Form to Medtronic
  • Distribute the notice to any relevant personnel within the organization or any organization which may have received the affected devices.
  • Keep a copy of the notice at the facility.

Further questions about the recall can be directed to Medtronic Technical Services at 1-888-826-5603, or via email at rs.navtechsupport@medtronic.com.

As the FDA continues to monitor this recall, healthcare professionals and consumers are encouraged to report any related incidents or issues to the agency’s MedWatch program.


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