US FDA put out a class I recall notice and sent health-care providers a warning to avoid using Monteris Medical's NeuroBlate probes after at least one patient bled to death after the probe overheated. The agency says it can't conclude for sure the patient death was caused by the device, which is used to support brain surgery.
Patients undergoing surgery could be at risk of injury or death from Monteris Medical Inc.'s NeuroBlate probe, part of the NeuroBlate System, according to US FDA. The agency announced it has known about the problem, in which the surgical tool has been reported to overheat, since October and now has designated it a high-risk class I recall.
"The FDA has received Medical Device Reports (MDRs) related to overheating of the probe, including one report of a patient...
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