Medtronic’s Cranial Software Recalled Due to Risk of Inaccuracy

The FDA has issued an update on Medtronic’s Nov. 11 recall of its Synergy Cranial and StealthStation S7 cranial software, deeming it a Class 1 recall because of the risk of serious injury or death to patients.

The reason for the recall is the potential for receiving an inaccurate biopsy depth gauge view. The 943 affected products were distributed from May 1, 2019, to Oct. 29, 2021.

If the graphical biopsy depth gauge is no longer synchronized with other navigation views during neurosurgery, it may result in “tissue injury, including potential for life-threatening injury,” the FDA said.