Medtronic Recalls Some Versions Of Software Used For Cranial Surgery

Medtronic Plc MDT has initiated a recall for some versions of its StealthStation S8 application. The FDA deemed software recall as Class I, the most serious kind.

The medical device giant is recalling the StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error that caused numbers or letters to be missing from the displayed text and replaced by a space in either the “distance to target” or “tip stop point” display during navigation.

The missing digit may cause the mechanical depth stop to be set too short or too long, causing the surgeon to use an incorrect measurement to place the biopsy tip stop during navigation.

Performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.

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

The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during neurosurgery (treatment of diseases or disorders of the brain and spine).

The StealthStation is indicated for use in any medical condition where stereotactic surgery of the brain or spine may be appropriate and where reference to a rigid anatomical structure, such as the skull.

Procedures may include tumor resections, general/pediatric ventricular catheter placement, depth electrode, lead and probe placement, and cranial biopsies.

The company’s Urgent Medical Device Correction letter issued April 10 states that it plans to work to coordinate a software update. Medtronic intends to offer the update at no charge to resolve the error.

Price Action: MDT shares are down 1.41% at $82.10 at last check Wednesday.

Photo by Tony Webster via Wikimedia Commons