Monteris Medical recalled its NeuroBlate System and coinciding Laser Delivery Probes due to numerous instances of device malfunctions, according to a March 22 recall alert from the FDA.
Here are five things to know.
1. The NeuroBlate Laser Delivery Probes are small, carbon dioxide-cooled catheters surgeons can use for minimally invasive entry into a patient's brain. The Monteris Medical NeuroBlate System, which contains the probes, is used to ablate, coagulate or destroy cells in brain tissue during surgical procedures.
2. Monteris Medical received several reports of the NeuroBlate Laser Delivery Probes exhibiting unexpected heating and damage to the probe's tip. "This could cause unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain," the FDA wrote.
3. The agency labeled the situation a Class I recall — the most serious type — in which use of affected devices could cause serious injuries or death.
4. The recall applies to 52 NeuroBlate Systems distributed throughout the U.S. and Canada between April 2013 and July 2017.
5. Monteris Medical shared three product advisories about the affected devices in late 2017. However, the FDA expressed "concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating," according to the recall alert. The FDA recommends healthcare providers use alternative procedures, if possible, until Monteris Medical identifies appropriate mitigation strategies for the faulty NeuroBlate Systems.