Select Monteris Medical NeuroBlate systems have been recalled by the U.S. Food and Drug Administration for unexpected heating of its probe during surgery on the brain.
The FDA identified the NeuroBlate system in a Class I recall, the most serious kind, which indicates potential for serious injuries or death.
NeuroBlate is a device used for minimally-invasive entry into a patient’s brain during surgery. It is used to remove (ablate), thicken or solidify (coagulate) or destroy (nectrotize) cells in the brain tissue.
The problem with NeuroBlate is there has been an unexpected heating issue, which could damage the tips of the probe when they interact with the MRI system used to guide the device. This could cause catastrophic injury to a patient’s brain.
The recall notice stated this problem could cause “unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow CO2 cooling gas inside the probe to leak into the brain.”
One patient suffered an intracranial hemorrhage and died, according to one of many reports filed with the FDA.
Though Monteris issued three product advisories between October and December 2017, the FDA is concerned the company has not taken sufficient steps to address the unintended probe tip heating up and still putting patients at risk of serious injury.
The FDA is warning doctors to use an alternative medical device if possible, and to use the device with “extreme caution” if they absolutely have to.
The recall has affected 52 devices in the United States, with the exception of three in Canada. It was manufactured and distributed between April 2013 and July 2017.
Below is information on the affected device:
Name: Monteris Medical NeuroBlate System and Laser Delivery Probes
Product codes: GEX, HAW
Models: SideFire 3.3 mm (SFP) Directional Laser Probe (sizes 000-5), FullFire 3.3 mm DTP Diffusing Tip Laser Probe (sizes 000-5), FullFire Select 2.2 mm Diffusing Tip Laser Probe (sizes 000-5)
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If you or a loved one suffered injuries due to the NeuroBlate system, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new NeuroBlate lawsuits across the country, and you may be entitled to financial compensation.
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