Medtronic StealthStation Software Subject of Class I Recall

Megan Brooks

Disclosures

January 06, 2022

Medtronic has recalled the Synergy Cranial and S7 Cranial software contained in the StealthStation System because of potential inaccuracies caused by the biopsy depth gauge cycle view, the US Food and Drug Administration (FDA) has announced on its website.

The StealthStation helps neurosurgeons precisely locate anatomic structures during neurosurgical procedures.

"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," the FDA notice warns.

Such injuries include hemorrhage, unintended tissue damage, or permanent neurologic injury.

The FDA has identified this as a Class I recall, the most serious type, because of the risk for serious injury or death. There have been four complaints regarding this device issue, but no reported injuries or deaths.

The recall included 943 devices distributed in the United States between May 1, 2019, and October 29, 2021. Full product details are listed on the FDA's website.

Medtronic has sent a letter to healthcare professionals notifying them of this potential problem.

Questions related to this issue can be addressed to Medtronic Technical Services at 1-888-826-5603 or emailed to rs.navtechsupport@medtronic.com.

Adverse reactions or quality problems related to this recall should be reported to the FDA's MedWatch program.

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