FDA boosts Medtronic recall of brain surgery navigation software

The FDA is alerting healthcare providers to a software recall from Medtronic for its neurosurgery navigation software after reports of potentially inaccurate measurements being displayed during brain procedures.

The agency handed down a Class I recall label to the issue, its most serious risk designation. Medtronic said it had received 28 complaints but no reported patient injuries or deaths. 

The medtech giant previously reached out (PDF) to providers with a correction letter in April, saying a software update would be forthcoming. The issue affects the company’s StealthStation S8 program; no products need to be returned to the manufacturer.

According to the FDA, the issue spanned 876 StealthStation systems distributed in the U.S. and included versions 1.2.0, 1.1.0, 1.0.3, 1.0.2 and 1.0.1.

The system’s cranial software aims to help neurosurgeons locate rigid anatomical structures during an operation, such as portions of the skull. It is employed in various procedures including brain tumor removals, biopsies and the placement of catheters or stimulating electrode probes.

Medtronic said the problem lies in the on-screen displays of submillimeter-sensitive information such as “distance to target” or “tip stop point,” which guides the depth of a biopsy needle. In some cases, a character may be replaced by a blank space.

The company gave an example of the error, showing the dropped single digit in “Distance To Target: 8_.5 mm.” Medtronic said that in each complaint, the issue was identified and only resulted in a brief delay of the procedure.

Medtronic received a separate Class I recall designation for its StealthStation S8 software last December after a glitch was identified that could cause a pre-op plan to inadvertently shift to a different anatomical location.