|The FDA is providing preliminary information about the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System, and bringing to your attention a Class I recall for the device. The FDA has received medical device reports (MDRs) related to overheating of the probe, including one report of a patient who experienced an intracranial hemorrhage and died, although causality with the device malfunction cannot be concluded with certainty. Monteris issued three product advisories between October and December 2017, which were part of the Class I recall; however, the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating. We are working with the manufacturer to address these concerns.
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