Once again, Medtronic has issued a product correction for its surgical navigation software, earning the StealthStation platform its fifth Class I recall categorization from the FDA in as many years.
The system is designed to be used in both open and percutaneous surgical procedures, during which it relies on hardware and software tools, including specialized instruments and tracking algorithms, to monitor the positioning of surgical tools throughout a procedure. Surgical teams can also use the platform to map out their approaches before a procedure begins, then use those plans to guide the actual surgery.
According to a recall notice published Tuesday by the FDA, certain versions of the StealthStation software have been found to contain a glitch that can cause a pre-surgery plan in the system to shift following a change in its initial test. If that happens and the plan inadvertently changes to a different location for the surgery, it could result in serious health issues, per the FDA, including death.
To date, however, Medtronic has not reported any injuries or deaths associated with the issue.
The recall—which constitutes only a product correction rather than a full-on removal from the market—concerns only versions 2.0 and 2.0.1 of the StealthStation S8 application, which have been distributed since the start of 2022. That reportedly comprises just over 2,100 of the systems in use in the U.S.
In a letter sent to affected customers in late September, Medtronic advised them not to change the reference exam ahead of certain procedures. If they do, rather than attempting to simply revert to the original reference exam, they’ll have to manually correct the surgical plan or restart the whole process.
Medtronic is also in the process of developing a software update to correct the glitch and will contact affected facilities to coordinate the update once available.
The StealthStation software has racked up a handful of Class I recall notices since its 2017 FDA clearance.
Another of the classifications handed down earlier this year was something of a twofer: It described a pair of issues with the cranial software used with StealthStation S7 and i7 systems, both resulting in a loss of synchronization between the software’s display and surgical tools, where the StealthStation screen may show an inaccurate depiction of the tools’ locations in the body.
A similar issue was the cause of the preceding recall, which began in late 2021 and described how an issue with the software’s Biopsy Depth Gauge could cause it to display an incorrect representation of a biopsy needle’s position, which could in turn lead to tissue damage or—if the issue is caught in time—a delayed or aborted procedure.