Possible deadly error, brain scanning device used by surgeons recalled by FDA


MARYLAND (ABC4 News) – A device designed to help with brain surgery and analysis has been recalled by the FDA. It is a class 1 recall, which means use of these devices may cause serious injuries or death.

The Stealthstation auto-registration feature has been recalled due to inaccuracies during deep brain stimulation procedures (DBS).

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The DBS Software provides images of a patients brain to help surgeons navigate surgical tools and implants used during a deep brain stimulation (DBS) procedure.

According to the FDA, ” Medtronic has recalled the auto-registration feature of the StealthStation 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 system.

What this does in simple terms is a surgeon tries to place leads that help in mapping a patients brain could be pushed into the wrong place resulting in serious or life threatening harm to the patient.

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As of June 2020, a total of 33 medical device reports were identified: 22 related to the device malfunction, and 11 related to the injuries.

This is a video on YouTube that shows how the device is supposed to work.

For more information about the recall go to the FDA’s website

Copyright 2020 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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