Monteris issued 3 separate advisories from October to December 2017 regarding unintended probe tip heating with the NeuroBlate System. However, FDA is concerned that information provided by the manufacturer had not sufficiently mitigated the risk of unintended heating.
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 suit and our lawyers can help.
What’s the Problem?
“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 available,” FDA said. “The benefits and risks of the device, as well as the availability and benefits and risks of alternative treatment modalities, should be considered on an individual patient basis. Health care providers who do not believe there is a viable alternative should use the device with extreme caution.”
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 Brain Damage
Monteris Medical issued a nationwide recall for the NeuroBlate probe and system on October 5, 2017. The U.S. Food & Drug Administration (FDA) designated it as a Class I Recall, after several reports surfaced of unintended heating and damage to the probe, which may have resulted in damage to surrounding brain tissue.
Can I File a Class Action?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against Monteris Medical, the maker of the NeuroBlate laser delivery probe, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now. PLEASE NOTE: Our attorneys have decided against the filing of a class action lawsuit in this litigation, and instead are filing individual lawsuits on behalf of injured parties and/or their family members. We strongly believe that individual suits, and not a class action, are far more beneficial to our clients in terms of overall payout, lawyer fees, and control over their own cases. Contact us today to learn more about your legal rights.
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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 by 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.