Medtronic Synergy Cranial Software Class 1 Recall

FDA has classified as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software is used with the company’s StealthStation Surgical Navigation System, and provides detailed three-dimensional images of a patient’s brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery.

“During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain,” a recall notice says. “In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.”