The US Food and Drug Administration (FDA) has issued a Class I recall for a piece of Medtronic software used in locating anatomical structures during brain surgeries after it was found to display faulty text that potentially misleads surgeons.
The Class I recall, the most serious type of recall, was issued for four separate versions of Medtronic’s StealthStation S8 application, designed to be used with a surgical drill, after customer complaints about a software error causing numbers or letters to be missing from the displayed text and replaced by a space. This could cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation in neurosurgery.
The FDA states that performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.
Medtronic added that they have received 28 reports related to the issue with no injuries or deaths caused because of the error. The company has now issued an Urgent Medical Device Correction letter, stating that they are working on a free update to the software designed to address the specific issue. The affected software versions are versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.
It follows almost a year after Medtronic’s previous Class I recall for some of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a lack of energy being emitted from the devices.
Elsewhere in FDA recalls, OptumHealth has similarly been hit with a Class I recall over its infusion system designed to deliver medications or fluids to a patient via subcutaneous, intravenous, or perineural and epidural administration.
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