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# Medtronic Recalls Neurosurgical Navigation Software
- URL: https://www.fdaweb.com/medtronic-recalls-neurosurgical-navigation-software/
- Published: 2022-01-06T12:00:00.000Z
- Updated: 2026-09-14T17:27:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150879

Medtronic has recalled its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the device’s Biopsy Depth Gauge Cycle View. “If the user encounters the software issue where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, it may result in a prolonged procedure, the need for an additional surgical procedure, aborted procedure, tissue injury, including potential for life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death,” according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-synergy-cranial-and-stealthstation-s7-cranial-software-due-potential-risk?ref=fdaweb.com). FDA says there have been four complaints about the issue, but no reported injuries or deaths. The device aids in precisely locating anatomical structures during neurosurgical procedures.