The FDA deemed the recall of Medtronic (NYSE: MDT) StealthStation S8 software Class I, the most serious kind.
This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall on Sept. 27, 2023.
StealthStation is used for any medical condition in which the use of stereotactic surgery may be appropriate. It keeps track of surgical tools’ locations in relation to a patient’s anatomy by using images of the patient. The system shows the surgeon a tool’s location and the surgeon can plan the path for the tools and see how they should move.
During surgery, the software helps surgeons see if the tool position matches the plan, guiding them along the right path. The tools help find body parts during brain surgery, both open and less invasive, according to an FDA notice.
Medtronic Navigation Inc. recalled the software due to a glitch that can make surgical plan data shift location after changing the initial test. This can cause surgical plan data to wind up in an unintended location for surgery. The use of the affected product could lead to serious adverse health consequences, including death. However, Medtronic reports no injuries and no deaths related to the issue.
The company told affected customers to not change the reference exam in cranial or ear, nose and throat (ENT) procedures if the data is defined on a reference exam merged with pre-merge type or diffusion series. Users can’t recover the incorrect data by reverting to the original reference exam. They must manually update existing plans or make new plans to resolve this issue.