Medtronic recalls StealthStation neurosurgery navigation software, again

If Medtronic is currently experiencing a sense of déjà vu, it’s for good reason. About three years after launching a Class I recall of some of its StealthStation surgical navigation software, the company has once again received the FDA’s most serious classification for yet another recall of the software, and for a very similar issue.

The latest recall, initiated by Medtronic last November, concerns newer versions of the Synergy Cranial and S7 Cranial software used with the StealthStation system. The system builds 3D models of a patient’s brain to help surgeons pinpoint the exact location of certain anatomical structures during both open and percutaneous neurological procedures.

In some cases, however, the software’s Biopsy Depth Gauge Cycle View can become unsynchronized from the rest of the system, potentially displaying an inaccurate representation of the positioning of a biopsy needle.

If this occurs, according to the FDA’s safety notice, the software glitch could result in a procedure taking more time than usual or being aborted altogether, and could also require additional surgeries. Furthermore, an incorrect biopsy could lead to tissue injury, including life-threatening conditions like hemorrhage, unintended tissue damage and permanent neurological injury.

As of the Jan. 6 notice, only four complaints have been filed regarding the issue, with no injuries or deaths reported.

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In a November letter to healthcare providers using the StealthStation system, Medtronic asked that they apply a warning and instructional notice to affected devices until a software update has been released.

In the meantime, the medtech giant offered a workaround. When operating the software, surgical teams should use the system’s 2D Guidance View to compare the Biopsy Depth Gauge’s navigation with a real-time camera feed to ensure the biopsy needle is correctly positioned, manually resetting the navigation as needed if a discrepancy is detected.

The recall covers software sold between May 2019 and October 2021. That includes more than 2,500 devices in use around the world, nearly 950 of which are distributed across every state of the U.S.

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The latest issue with the StealthStation system echoes the one that landed Medtronic another Class I recall in late 2018, which remains open, per the FDA.

Once again, the Biopsy Depth Gauge graphic was to blame. According to a company notice at the time, if the system’s navigation didn’t align with the actual surgical plan, it could result in an inaccurate visualization of the biopsy needle, potentially causing surgeons to insert the needle too deeply and damage healthy tissue.

In that case, the recall spanned a total of 5,487 systems in use across the U.S. and in dozens of other countries around the world.