The FDA confirmed that a recall of cranial software from Medtronic (NYSE:MDT) has been designated as Class I, the most serious kind of recall.
Both the Synergy Cranial and StealthStation S7 Cranial software are included in the recall, which affects 943 devices distributed between May 1, 2019, and Oct. 29, 2021, in the U.S. Medtronic initiated the recall on Nov. 11, 2021, confirming the receipt of four complaints related to the issue with no reported injuries or deaths.
Fridley, Minnesota-based Medtronic’s StealStation system, which uses both Synergy Cranial software of StealthStation S7 Cranial software, helps to precisely locate anatomical structures in neurosurgical procedures. The recall was initiated due to potential inaccuracies caused by the Biopsy Depth Gauge Cycle View, according to an FDA notice.
If a user encounters a software issue in which the graphical Biopsy Depth Gauge is no longer synchronized with other navigation issues, it may result in a prolonged procedure, the need for an additional surgical procedure, an aborted procedure and/or tissue injury, which includes the potential for life-threatening injury that could lead to death.