The FDA today issued a recall for select Monteris Medical NeuroBlate systems and laser delivery probes over issues with unexpected MRI-related heating and damage to the tip of the probe that could cause serious injuries.
The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death.
The NeuroBlate laser delivery probes are carbon dioxide-cooled catheters designed to allow minimally invasive entry into a patient’s brain, and are part of the company’s NeuroBlate system used to remove, thicken, solidify or destroy cells in brain tissue, the FDA said.
The federal watchdog said the devices are being recalled due to unexpected heating and possible damage to the tip of the probes when they interact with an MRI system. The 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,” according to its recall notice.
The FDA said it has received medical device reports related to overheating of the probe which include a single patient who experienced an intracranial hemorrhage and died, though the device malfunction could not be deemed the cause with certainty.
“Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, the FDA recommends health care providers should strongly consider treating patients using alternative procedures if available. Health care providers who do not believe there is a viable alternative should use the device with extreme caution,” the agency wrote in its notice.
The recall affects a total of 52 devices in North America, with 49 in the US and 3 in Canada. Affected devices have product codes GEX and HAW and include the SideFire 3.3mm direcitonal laser probes in sizes 000 to 5, the FullFire 3.3mm DTP diffusing laser tip probe in sizes 000 to 5 and the FullFire Select 2.2mm diffusing tip laser probe in sizes 000 to 5.
Recalled items were manufactured between April 2013 and July 2017, the FDA said.
The FDA said that Monteris issued three product advisories between October and December 2017 related to the issue, but that the FDA “has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating.”
The federal watchdog said that “until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, healthcare providers should strongly consider treating patients using alternative procedures if available.”