FDA Recalls Software Used with Surgical Navigation System

Medtronic has recalled software used during biopsy procedures due to reports that the products—Synergy Cranial Software and StealthStation S7 Cranial Software—provided incorrect information that could result in serious or life-threatening harm to patients. 

The FDA has identified this as a Class I recall, the most urgent type. The software is used with the StealthStation Surgical Navigation System to provide detailed 3D images of a patient's brain that help neurosurgeons safely guide surgical tools and implants during surgery.

During a biopsy procedure, the software monitor may incorrectly show that the tip of the surgical tool has not reached the planned target, and may prevent the surgeon from seeing the location of the tool in the patient's brain. If this software defect occurs, the neurosurgeon could insert the tool too deeply and damage the patient's healthy tissue, brain, or blood vessels.

On September 21, 2018, Medtronic sent an Urgent Medical Device Correction notice to customers, instructing them to notify staff members of the issue. The recall was initiated on September 26, 2018, and on December 28, 2018, Medtronic reported that the company was continuing to follow up with customers.