Monteris Medical is recalling NeuroBlate System and Laser Delivery Probes – small, carbon dioxide (CO2)-cooled catheters that allow for minimally invasive entry into a patient’s brain – because in some cases the probes can interact with the MRI system used to visualize the position of the catheter and cause unexpected heating. This issue 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 brain probes are part of the NeuroBlate system, which is used during surgical procedures to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells in brain tissue. Until appropriate mitigation strategies have been identified by Monteris Medical and evaluated by the Food and Drug Administration (FDA), the FDA recommends that health care providers “strongly consider treating patients using alternative procedures if possible. Health care providers who believe there is no viable alternative should use the device with extreme caution.”
The issue affects patients who need to undergo brain tissue ablation and neurosurgeons who may be using the NeuroBlate system and the Laser Delivery Probes. A total of 52 devices are affected by this recall, 49 of which are in the U.S. and three in Canada. The devices were manufactured and distributed from April 2013 to July 2017.
Any adverse events or quality problems related to this recalled device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice