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# Medtronic Recalls Brain Stimulation Software
- URL: https://www.fdaweb.com/medtronic-recalls-brain-stimulation-software/
- Published: 2020-06-01T12:00:00.000Z
- Updated: 2026-09-14T16:16:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146899

Medtronic has recalled the auto-registration feature of its StealthStation Deep Brain Stimulation (DBS) Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device. An FDA [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-stealthstation-auto-registration-feature-due-inaccuracies-during-deep-brain?utm%5Fcampaign=2020-06-01%20Recall%20Medtronic%20StealthStation&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the inaccurate registration data could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures, which could result in serious or life-threatening patient harm. To date, 33 medical device reports were identified — 22 related to device malfunction and 11 related to injuries. The StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System provides images of a patient’s brain to help surgeons navigate surgical tools and implants used during DBS procedures.