Image of neurosurgeons doing brain surgery using a Medtronic device.

Neurosurgery Device Recalled by Medtronic

The FDA has issued a Class I recall for Medtronic’s Synergy Cranial and StealthStation S7 Cranial Software after concluding that the software could not function accurately during brain surgeries.

The Synergy Cranial and StealthStation S7 Cranial Software were designed to precisely locate various anatomical structures in the brain in order to aid surgeons attempting the delicate procedures of brain surgery. According to the FDA recall announcement, the software’s biopsy depth gauge can become desynchronized with the rest of the device and cause inaccurate readings.

According to the FDA, this error can lead to a prolonged procedure, additional surgical procedures, aborted procedures, tissue injury, hemorrhage, permanent tissue damage, neurological injury, or death.

This recall will affect 943 devices distributed between May 1, 2019 and October 29, 2021. Medtronic sent a notice to healthcare providers relating to the potential inaccuracy with information for contacting Medtronic Technical Services. 

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