FDA issues Class I recall for Medtronic’s surgery StealthStation

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Names: StealthStation S8 Application Version 2.0 and 2.0.1
• Product Codes: See Recall Database Entry
• Model Number: 9735762
• Distribution Dates: January 7, 2022, to October 2, 2023
• Devices Recalled in the U.S.: 2,109
• Date Initiated by Firm: September 27, 2023

Device use
The StealthStation System is used for any medical condition in which the use of stereotactic surgery may be appropriate. This system keeps track of where surgical tools are in relation to a patient’s anatomy by using images of the patient. As the surgeon works, the system shows where the tool is on these images and models where the surgeon picked. Before surgery, the surgeon can plan the path for the tools and see how they should move. During surgery, the software helps the surgeon see if the actual tool position matches the plan, guiding them along the right path. These tools help find body parts during brain surgery, whether it’s open or less invasive. They’re useful for any medical situation where precise surgery might be needed.

Reason for recall
Medtronic Navigation Inc. is recalling StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make the surgical plan data shift location(s) after the initial test is changed. This can cause the surgical plan data to be in an unintended location for the surgery.

The use of affected product may cause serious adverse health consequences, including death.

There have been no reported injuries. There have been no reports of death.

Who may be affected

• Medical professionals that use this device to assist in stereotactic surgeries.
• People undergoing stereotactic surgery.

What to do
On September 27, 2023, Medtronic Navigation Inc. sent all affected customers an Urgent Medical Device Correction Letter.

The letter requested customers to:

• Not change the reference exam in Cranial or ENT procedures, if the surgical planning data is defined on a reference exam merged with pre-merge type or diffusion series. The incorrect surgical plan data cannot be recovered by reverting to the original reference exam. To resolve this issue, the user must manually update the existing plans to the original locations or make new plans.
• Review the provided information and share with all physician users.
• Send the completed Customer Confirmation Form to Medtronic via email at [email protected].
  • Medtronic will contact your facility to coordinate the software update when it is available.

MB Bureau