FDA Posts Notice on Medtronic Cranial Software Recall

Medtronic recalled Synergy Cranial Software and Stealth Station S7 Cranial Software in September 2018 because of inaccuracies displayed during surgical procedures. The notice says FDA has identified this as a Class I recall, the most serious type of recall.

The U.S. Food and Drug Administration recently added a new MedWatch Safety Alert recall notice to the FDA Recalls page concerning Medtronic's recalled Synergy Cranial Software and Stealth Station S7 Cranial Software. They were recalled in September 2018 because of inaccuracies displayed during surgical procedures, according to the notice.

It says FDA has identified this as a Class I recall, the most serious type of recall, because use of the software may cause serious injuries or death. The recall affects model numbers 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7; and 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0. These were manufactured and distributed from Aug. 31, 2011, to Oct. 16, 2018. A total of 5,487 have been recalled, according to the notice.

The products are used with the StealthStation Surgical Navigation System to provide detailed three-dimensional images of a patient's brain to help neurosurgeons safely navigate surgical tools and implants used during brain surgery. Medtronic recalled them due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm; according to the notice, 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. 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.

Medtronic on Sept. 21, 2018, sent an Urgent Medical Device Correction notice to customers. The company reported Dec. 28, 2018, that it was continuing to follow up with customers about the problem.

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