Medtronic has recalled S7 Cranial and Synergy Cranial software from the StealthStation system because of errors in the biopsy depth gauge view, the US Food and Drug Administration has announced on their website.
The StealthStation aids neurosurgeons to pinpoint anatomic structures during neurosurgical procedures.
“If the user encounters a software issue where the depth gauge for graphical biopsy is no longer synchronized with other navigation views, it may result in a prolonged procedure, the requirement for an additional surgical procedure, aborted procedure, tissue damage and even the risk of life-threatening injuries,” the FDA notice warns.
These injuries include hemorhage and unintentional tissue damage and permanent neurologic injury.
This recall has been classified by the FDA as a Class I recall. This is due to the risk of serious injury or even death. There were four complaints about this device issue, but no injuries or deaths have been reported.
The recall affected 943 devices distributed in the United States between May 1 to October 29, 2021. The complete product information is available on the FDA’s website.
Medtronic has sent a letter to healthcare professionals, informing them of the potential issue.
Questions related to this issue can be addressed to Medtronic Technical Services at 1-888-826-5603 or emailed to [email protected].
Adverse reactions or quality problems associated with this recall must be reported to the FDA’s MedWatch program.
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