Medtronic recalls neurosurgery navigation system due to software error

Medtronic recalled its surgical navigation system for neurosurgery due to a software error causing incorrect biopsy tip stop measurements. The FDA reported 28 complaints but no injuries or deaths. The Stealthstation system assists in locating anatomical structures during neurosurgery, but it has faced several recent recalls, including one last year for software issues with the Stealthstation S7 and S8 platforms.

The latest recall involves the Stealthstation S8 system, where a software error can cause missing numbers or letters in displayed text, leading to incorrect depth stop settings. This could result in serious injuries, categorized as Class I recalls by the FDA. Medtronic plans to issue a software update to correct the error, informing customers via letter. The recall affects 876 devices in the U.S. Previous recalls in 2023 and earlier posed similar risks during cranial procedures due to software problems impacting surgical planning and navigation synchronization.