FDA Recalls Brain Surgery Device Due to Heating Problem

FDA alerted doctors to a problem with the Monteris Medical NeuroBlate probe in which the device may become unexpectedly heated during certain types of brain surgery.

At least one patient has died from an intracranial hemorrhage that may be related to overheating of a device used during brain surgery. FDA said it has received reports of overheating of Monteris Medical NeuroBlate probes.

The NeuroBlate probes are small, carbon dioxide-cooled catheters designed to allow minimally invasive entry into a patient's brain. The probes are part of the NeuroBlate System, which is used to remove, thick or solidify, or destroy cells in brain tissue. The device was developed as an alternative to traditional craniotomies, and it was cleared by FDA in 2013.

FDA said that in some cases, the NeuroBlate probes interact with the MRI system used to visualize the position of the catheter and cause unexpected heating and damage to the tip of the probe, which in turn could allow the carbon dioxide inside the probe to leak into the brain. Plymouth, MN-based Monteris issued three product advisories between October 2017 and December 2017, which were part of a Class I recall, but FDA said the information the company provided may not have sufficiently mitigated the risk of unintended probe tip heating. 

Until appropriate mitigation strategies have been identified by Monteris and evaluated by FDA, the agency said healthcare providers should strongly consider treating patients using alternative procedures if available. If no viable alternative procedure is believed to be available, FDA said the device should be used with "extreme caution."

Last year Monteris raised $26.6 million in a series C financing intended to fund R&D activities, clinical research, and commercial expansion. The company is backed by Versant Ventures, SightLine Partners, Birchview Capital, and BDC Capital.
 

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The FDA didn't recall it. The FDA classified actions already taken by the company as a Class I recall. The FDA also provided advice to physicians on its use, but took no further action with respect to the product itself.