What is the NeuroBlate Probe?
The Monteris Medical NeuroBlate System is a robotically controlled laser thermotherapy that uses MRI-guided light to ablate (remove) unwanted tissue in the brain. Monteris markets the procedure as minimally-invasive compared to traditional brain surgery, requiring only a tiny hole in the skull about the diameter of a pencil.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications following a NeuroBlate procedure, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit against the manufacturer and our lawyers can help.
NeuroBlate Recall
The NeuroBlate System and Laser Delivery Probes were the subject of an FDA Class I recall in March 2018, after multiple reports surfaced of unintended heating and damage to the probe, which may have resulted in injuries to surrounding brain tissue.
FDA said damage to the probe appears to have been caused by an interaction between the thermocouple in the probe, and the MRI environment. These events were deemed not to be related laser energy delivery, and have been associated with damage to the tip of the probe implanted within the brain (e.g., charring, release of carbon dioxide).
Which Devices are Affected?
The NeuroBlate Probe recall affects the following devices with product codes GEX and HAW:
- SideFire 3.3 mm (SFP) Directional Laser Probe (sizes 000-5)
- FullFire 3.3 mm DTP Diffusing Tip Laser Probe (sizes 000-5)
- FullFire Select 2.2 mm Diffusing Tip Laser Probe (sizes 000-5)
A total of 52 probes are affected by the recall, 49 of which were sold in the U.S., according to the FDA. The devices were manufactured between April 2013 and July 2017.
NeuroBlate Probe Death
FDA said in its recall announcement that it had received multiple reports related to overheating of the NeuroBlate Probe, including 1 report of a patient who died after experiencing an intracranial hemorrhage, “although causality with the device malfunction cannot be concluded with certainty.”
NeuroBlate Side Effects
Complications resulting from a malfunctioning NeuroBlate probe may include:
- Neurological deficits (e.g., focal motor deficits, aphasia, cognitive changes)
- Increased intracerebral edema or pressure
- Intracranial bleeding
- Visual changes (e.g., visual field deficits, blurry vision)
- And more
About Class Action Lawsuits
Although we are a nationally recognized class action firm, the Medical Device Litigation Group at our law firm has decided against the filing of a NeuroBlate Class Action Suit, and is currently filing individual claims on behalf of injured people and/or their family members who were harmed by the Monteris Medical NeuroBlate System / NeuroBlate Laser Delivery Probes.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual NeuroBlate lawsuits on their behalf.
Do I Have a NeuroBlate Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in NeuroBlate lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one had complications from a NeuroBlate procedure, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.