Medtronic Synergy Cranial

2022: Rejected Software Recall

In early January 2022, it became known that Medtronic was recalling the defective Synergy Cranial and StealthStation S7 Cranial software for neurosurgical operations. The manufacturer confirmed receiving four complaints related to the issue, with no injuries or deaths reported.

In the event that the user encounters a software problem in which the graphical biopsy depth meter ceases to synchronize with other navigation data, this can lead to a delay in the procedure, as well as the need to perform an additional surgical procedure, interrupt the procedure, or injure tissues, which includes a potential life-threatening injury that can be fatal to the patient.

Medtronic recalls defective neurosurgical software Synergy Cranial

The US Food and Drug Administration (FDA) has specified that the Medtronic cranial device software recall has been classified as Class I. This group includes critical software errors that may result in the death of users by the system or devices, and is the most serious type of recall. The StealthStation system with Synergy Cranial and StealthStation S7 Cranial software was also withdrawn in January 2019, the software given was also withdrawn due to reports of inaccurate information displayed during biopsy procedures. Synergy Cranial and StealthStation S7 Cranial are included in the recall, which affects 943 devices distributed from May 1, 2019 to October 29, 2021 in the United States.

Medtronic's StealStation system, which uses Synergy Cranial and StealthStation S7 Cranial, helps pinpoint the location of anatomical structures in neurosurgical procedures. The recall was initiated due to potential inaccuracies caused by the cyclical presentation of the biopsy depth sensor, according to the FDA notice. ^[1]

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