January 18, 2022

FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious.

The System aids in precisely locating anatomical structures in neurosurgical procedures.

The recall was initiated because of potential inaccuracies caused by the Biopsy Depth Gauge Cycle View.

There have been four complaints, and no reported injuries or deaths.

Distribution dates were May 1, 2019 to October 29, 2021.

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