Studies have found that interaction between MRI systems and the NeuroBlate Laser Delivery Probes may cause unexpected heating and damage to the probes. When this occurs, brain tissue may become super-heated, resulting in severe brain damage and even death.
Free Confidential Lawsuit Evaluation: If you or a loved one had complications from a NeuroBlate procedure, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What is the NeuroBlate Probe?
The NeuroBlate laser delivery probe is a small, carbon dioxide-cooled catheter that allows for minimally invasive entry into a patient’s brain during surgery with Monteris Medical’s NeuroBlate System. The system combines a surgical laser, MRI imaging, and software to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells during brain surgery. NeuroBlate was approved by the U.S. Food & Drug Administration (FDA) on April 7, 2016.
Which Probes Were Recalled?
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)
FDA says a total of 52 probes are affected by the recall, 49 of which were sold in the U.S. The devices were manufactured from April 2013 to July 2017.
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
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.”
Can I File a NeuroBlate Suit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against Monteris Medical, the maker of NeuroBlate, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain potential health risk(s). In the case of the NeuroBlate Probe, our attorneys suspect that patients may be able to take legal action in light of claims that Monteris failed to adequately warn doctors and patients about the risk of brain damage.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of the NeuroBlate System, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the device’s manufacturer accountable for releasing an allegedly defective product into the marketplace, and to discourage other companies from engaging in similar conduct.
Do I have a NeuroBlate Lawsuit?
The Medical Device 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 were harmed during a NeuroBlate procedure, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.