FDA declares recall of Medtronic’s brain surgery support systems.
Medtronic has recalled several versions of its StealthStation S8 due to a software error that prevents numbers from appearing on the system display. The StealthStation supports head and spine surgeries, including catheter placements, tumor extractions, and biopsies. The missing display of crucial numbers like “distance to target” poses a risk to patients.
Although no injuries have been reported, the potential for serious harm, such as paralysis or death, has led the U.S. Food and Drug Administration (FDA) to classify the recall as Class I, the most severe type of recall.
Medtronic first announced the recall in April. A total of 876 StealthStation S8 units, distributed to surgeons between March 21, 2017, and March 22, 2024, are affected. The company received 28 complaints related to software versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1, prompting the recall.
Medtronic has informed affected customers through a letter, offering to coordinate a free software update to fix the issue.
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