FDA designates Class I recall for neurosurgery software

Editor's Note

The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death.

The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during neurosurgery, including tumor resections, ventricular catheter placement, cranial biopsies, and depth electrode, lead and probe placement.

According to the agency’s June 5 announcement, the recall of Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 of the software is due to risk of an error resulting numbers or letters a replaced by a space in either the "distance to target" or "tip stop point" display during navigation. Setting the mechanical depth stop too short or too long could result in using an incorrect measurement for placement of the biopsy tip stop during navigation,” potentially resulting in serious permanent injuries.    

Medtronic reports 28 complaints related to this issue. There have been no reported injuries or deaths.