The FDA deemed a recall of software for the Medtronic
(NYSE: MDT)
StealthStation S8 as Class I, the most serious kind.
Medtronic initiated a recall of some versions of its StealthStation S8 application on April 1. The recall affects versions 1.2.0, 1.1.0, 1.0.3, 1.0.2 and 1.0.1. It’s a correction, not a product removal.
The medtech giant recalled 876 devices in total, distributed between March 21, 2017, and March 22, 2024. This adds to a separate StealthStation S8 recall initiated last winter.
StealthStation with StealthStation Cranial software acts as an aid for locating anatomical structures during neurosurgery. Its indication includes any medical condition where stereotactic 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.
Procedures may include tumor resections, general/pediatric ventricular catheter placement, depth electrode, lead and probe placement and cranial biopsies.
Medtronic recalled the application after customer complaints about a software error, according to the FDA. The error may cause missing numbers or letters, replaced by a space, in the displayed text. These messages appear in either the “distance to target” or “tip stop point” display during navigation.
The missing digit may result in either a too-short or too-long mechanical depth stop. It may cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation. Performing a cranial procedure using incorrect placement could lead to serious permanent injuries. Those include brain, nerve or cerebrovascular damage, abnormal functions to the brain, spine or muscles, paralysis or death.
Medtronic reports 28 complaints related to the issue, with no reports of injuries or deaths.
The company’s Urgent Medical Device Correction letter issued April 10 states that it plans to work to coordinate a software update. Medtronic plans to offer the update at no charge, resolving the error. The FDA has additional information on its website.