Medtronic has initiated a recall of certain versions of its StealthStation S8 application, following customer feedback about a software glitch. The recall affects versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 of the software. This glitch causes numbers or letters to be omitted from the displayed text, impacting critical measurements such as the “distance to target” or “tip stop point” during neurosurgical navigation.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating it is the most serious type of recall due to the potential for significant health risks. The error could result in the incorrect setting of the mechanical depth stop, leading to the inaccurate placement of surgical instruments. This poses a risk of severe outcomes, including permanent brain or nerve damage, paralysis, or even death.
No injuries or deaths have been reported, though 28 complaints have been received. A total of 876 devices distributed between March 2017 and March 2024 are affected by the recall, which began on April 10, 2024. Medtronic plans to issue a free software update to correct the issue. This is the second recall for the StealthStation S8, following a previous one in December last year for versions 2.0 and 2.0.1 due to a similar software issue.