Monteris Medical’s NeuroBlate Laser Delivery Probe was recalled in October 2017, following reports of unintended heating and damage to the probe during minimally-invasive brain procedures. At least one death may be associated with a malfunctioning NeuroBlate Probe.
The medical device attorneys at Bernstein Liebhard LLP are investigating brain injuries and deaths that may be associated with the NeuroBlate Probe recall. If you or a loved one were harmed by this device during a minimally-invasive procedure to remove a brain tumor, please contact our office for a free, no-obligation NeuroBlate Probe lawsuit review by calling (888) 994-5118.
The NeuroBlate Laser Delivery Probe is a small, carbon dioxide (CO2)-cooled catheter designed to allow minimally invasive entry into a patient’s brain. It is a component of Monteris Medical’s NeuroBlate System, which combines a surgical laser, MRI imaging and software to remove or destroy cancer cells during minimally-invasive brain procedures. The system allows for the removal of brain tumors that were once considered inoperable.
Monteris Medical announced a recall for the NeuroBlate Probe in October 2017, after reports suggested that the device could be damaged by overheating when used in conjunction with the MRI system, an occurrence that could result in unintentional tissue damage.
The U.S. Food & Drug Administration (FDA) later designated the NeuroBlate Probe recall a Class I medical device recall, its most serious recall category. This indicates that use of the NeuroBlate Laser Delivery Probe could cause serious injury or death.
The FDA’s MAUDE database has received at least 12 reports of NeuroBlate Probe malfunction, including two that resulted in patient harm. In one case, a patient died of an intercranial hemorrhage that occurred after the probe overheated, though the FDA has not been able to confirm that the malfunction actually contributed to or caused the patient’s death.
The second patient suffered “limited thermal damage” to the brain tissue near the probe. However, the damage only occurred in the zone targeted for ablation.
Devices affected by the NeuroBlate Probe recall include the following models with product codes GEX and HAW:
The recall affects a total of 52 probes, including 49 sold in the United States. The remainder were sold in Canada.
The recalled NeuroBlate Probes were manufactured from April 2013 to July 2017.
“We are working with the manufacturer to address these concerns,” the FDA said to a letter to healthcare providers issued in March 2018. “Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, health care providers should strongly consider treating patients using alternative procedures if possible.”
Victims of NeuroBlate brain injuries associated with this recall may be entitled to financial compensation for medical bills, lost wages, and other damages. To learn more about the legal options available to you, please call our NeuroBlate Probe recall lawyers at (888) 994-5118.
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