FDA Issues Class I Recall on Cranial Surgery System Due to Software Error

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) has announced a Class I recall on Medtronic’s Stealthstation S8, a cranial surgery system, for a software error on Wednesday.

Class I recall is the most serious type of recall, use of these devices may cause serious injuries or death, according to the FDA.

Stealthstation S8 is a cranial surgery system that aids in locating anatomical structures during neurosurgery. The recall is made on Stealthstation S8 versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1, affecting 876 systems, which were distributed between March 21, 2017 and March 22, 2024.

Medtronic, the Minnesota-based medical device company, issued the recall on April 10 after customers complained that it was causing incorrect measurements and placements of a biopsy tip stop during surgical navigation.

Such a move could lead to serious and permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.

The FDA’s recall came nearly two months after the company’s urgent medical device correction letter was issued, which stated the company was working to coordinate a software update at no charge to customers to resolve the error.

Medtronic’s Cranial Surgery System

Typically, people undergo neurosurgery as a treatment for diseases or disorders of the brain and spine.

In its recall notice, the FDA said the StealthStation is “indicated for use in any medical condition where stereostatic 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.”

The cranial surgery system can be used for tumor resections, general ventricular catheter replacement, pediatric ventricular catheter placement, cranial biopsies, and placement of depth electrode probes.

To date, Medtronic has reported 28 complaints related to the issue. There have been no reports of injuries or death.

Individuals affected by the recall include people who have performed or received cranial surgeries with the StealthStation S8 and accompanying software.

The StealthStation 8 and accompanying software were recalled after customers complained that an error in the software was causing numbers and letters to be missing from the display text. Instead, a space would show up where the number or letter should be in the “distance to target” or “tip stop point.”

Medtronic’s April 10 letter urged customers to take certain actions. This includes verifying with Medtronic that the notification had been received, passing on the notice to individuals, including patients and other physicians, who may need to be made aware of the issue, and maintaining a copy of the recall notice within the health care facility.

The company is not requiring health care providers or surgeons to return the system. Physicians, surgeons, or patients with questions can contact Medtronic at 1-888-826-5603 or [email protected].

Patients who underwent cranial surgery in which the system was used should reach out to their physicians. Physicians have received confirmation forms that can be filled out and submitted to Medtronic. If any patients are experiencing health issues or adverse events, the FDA encourages making reports to the federal agency’s MedWatch program.

A History of Recalls

This is not the first recall for the StealthStation 8 System. The company issued a voluntary recall on Sept. 27, 2023, for over 2,000 of its applications due to a software glitch. The glitch can cause the surgical plan’s data to be in an unintended location for surgery, which can lead to serious consequences such as death.

No injuries and deaths were reported with that error.

Earlier in 2023, the company’s StealthStation 7 and i7 systems were recalled as a result of loss of synchronization between the software’s display and surgical tools. The system’s screen showed an inaccurate depiction of the tools’ locations in the body. A similar issue was the cause of another recall in late 2021.