The US Food and Drug Administration (FDA) has identified Medtronic’s recall of StealthStation S8 applications as Class I, the most serious recall.
The StealthStation System with the StealthStation Cranial software is designed to support the identification of anatomical structures during neurosurgery including the treatment of brain and spine diseases.
Medtronic is recalling the StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 based on customer feedback highlighting a software glitch.
The error causes the omission of numbers or letters from the displayed text, which are then replaced by a space, affecting the “distance to target” or “tip stop point” display during navigation.
The StealthStation is designed for situations where stereotactic surgery of the brain or spine is suitable. It can also be used where a rigid anatomical structure like the skull can be identified using anatomical images.
The FDA said the omission of numbers or letters may lead to incorrect settings of the mechanical depth stop. This could cause surgeons to use inaccurate measurements for the placement of the biopsy tip stop during navigation.
Improper placement during cranial procedures can result in permanent injuries like brain, nerve, or cerebrovascular damage, impairment of brain, spine, or muscle functions, paralysis, or even fatality, said the regulator.
Medtronic has received 28 complaints regarding this issue with no report of injuries or deaths.
Additionally, the medical technology firm said that the people receiving cranial surgery using the StealthStation S8 with Software Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 can be affected. Surgeons who perform these procedures with the recalled devices may also be affected.
In total, Medtronic has recalled 876 devices in total, distributed between 21 March 2017 and 22 March 2024. The recall was initiated on 10 April 2024.
The company has issued an Urgent Medical Device Correction letter stating its intention to introduce a software update at no charge to solve the error.
In December last year, Medtronic Navigation recalled StealthStation S8 application versions 2.0 and 2.0.1 due to a software glitch that shifted surgical plan data.
