NeuroBlate Class Action Lawsuit (Sep 2026 Update)

The NeuroBlate System, a brain laser device made by Monteris Medical, was recalled after reports that its probes could heat unexpectedly and damage brain tissue. The FDA posted the recall as Class 1 in March 2018. The FDA ended the recall in January 2021. It covered 52 systems distributed in the United States and Canada, after complaints that the system interacted unexpectedly with 1.5 Tesla MRI systems. No class action or MDL has been filed over the NeuroBlate System. Only individual claims exist: a $12.75 million settlement reported in February 2020 and a $9.7 million jury verdict in November 2021.

Latest NeuroBlate Lawsuit Updates

November 12, 2021: Jury Awards $9.7 Million Verdict

The Philadelphia Inquirer reported that a Philadelphia jury awarded $9.7 million to Michael Brassloff. He was hurt in a 2015 brain operation when a NeuroBlate 2.2 mm SideFire laser probe tip broke [1]. The jury assigned 42% of fault to Monteris Medical, 43% to neurosurgeon Kevin Judy and 15% to Thomas Jefferson University. Monteris had already settled with Brassloff before the trial.

January 21, 2021: FDA Terminates the NeuroBlate System Recall

The FDA recorded the NeuroBlate System Class 1 recall, number Z-0194-2018, as terminated on January 21, 2021 [2]. Termination came more than three years after Monteris Medical’s first advisory notice to NeuroBlate users in October 2017.

February 26, 2020: Law.com Reports $12.75 Million Settlement

Law.com reported that a surgical equipment company agreed to pay $12.75 million to a man who suffered brain damage [3]. The tip of one of its laser probes broke off during his surgery. The Inquirer later identified this as the settlement between Monteris Medical and Brassloff.

November 9, 2018: FDA Clears Modified NeuroBlate Probe

MedTech Dive reported that the FDA cleared a modified NeuroBlate probe and reiterated its April 2018 recommendations on the old metallic probe. The modified probe replaces the metallic thermocouple temperature sensor with a non-metallic fiber optic sensor [4].

March 22, 2018: FDA Issues Safety Communication

The FDA issued a safety communication and a letter to health care providers about NeuroBlate probes. Medscape reported on it [5]. The FDA asked providers who use the probes to weigh the risks.

March 20, 2018: FDA Posts Class 1 Recall

The FDA posted the NeuroBlate System recall, number Z-0194-2018, as Class 1. The firm had received complaints of an unanticipated interaction with 1.5 Tesla MRI systems.

October 5, 2017: Monteris Starts the Recall

Monteris Medical started the Z-0194-2018 recall by sending an advisory notice with added recommendations to NeuroBlate users. The FDA posted the recall about five months later, in March 2018.

March 25, 2016: Monteris Removes SideFire Select Probe

Monteris began removing the NeuroBlate SideFire Select 2.2 mm Directional Laser Probe, recall number Z-1614-2016. A report said the sapphire lens fractured during a procedure and CO2 entered the patient’s brain [6]. The FDA classed it as Class 1 and recorded it as terminated on March 10, 2017. This earlier recall is separate from the 2017 recall of the NeuroBlate System.

What Is the NeuroBlate System?

According to the FDA, as reported by Medical Product Outsourcing, the NeuroBlate System is used for MRI-guided neurosurgical ablation. Its laser probes are small catheters cooled by carbon dioxide (CO2) [7]. The probes allow small-opening entry into the brain. Surgeons use them to remove, thicken or destroy cells in brain tissue. Monteris Medical makes the device. The recall and claims on this page involve its probes.

Who May Be Affected?

Patients who had brain tissue ablation with the NeuroBlate System may be affected by the recall, according to the FDA notice that MPO reported. Recalled probes were made and distributed between April 2013 and July 2017. They include the SideFire 3.3 mm, FullFire 3.3 mm and FullFire Select 2.2 mm models. The verdict patient was operated on in 2015 for a benign tumor. The reported cases are individual claims. Whether a claim fits you depends on an individual legal review of your records.

Reported Injuries or Damages

The FDA reported several instances of unintended heating and damage to the probe. It said this may have harmed nearby brain tissue. These are agency findings. One FDA Medical Device Report involved a patient who suffered intracranial hemorrhage and died. Medical Design and Outsourcing reported that it was not conclusive, according to the FDA, that probe heating was the cause [8]. In late 2018, Monteris said more than 2,000 patients had been treated since 2013. Reports do not prove that the probe caused every injury. In the verdict case, the patient’s lawyer said he still has trouble with balance, walking and dexterity. He also has trouble with emotional stability and word choice. The lawyer said he developed a seizure disorder and Parkinson-like symptoms. These are the plaintiff’s lawyer’s descriptions of his condition.

Recall and Regulatory Background

The FDA determined the cause of the NeuroBlate System recall was device design. Of the recalled systems, 49 went to U.S. customers and 3 to Canada. MPO reported that Monteris issued three product advisories between October and December 2017. The FDA said it had concerns that the information had not sufficiently mitigated the risk of probe tip heating. A recall does not by itself establish that the maker is liable for any injury. Each claim depends on its own facts.

Evidence to Preserve

If you had a NeuroBlate brain procedure and were hurt, keep these items in one place:

• Operative and discharge records, including the name of the device used
• The NeuroBlate probe model and lot number, if a record shows them
• Imaging reports and scans taken before and after the procedure
• Follow-up and rehabilitation records, along with the bills for that care
• Photos or dated notes that describe your symptoms over time
• Messages with the hospital, the surgeon or the manufacturer
• Any letters you received about the recall

Keep originals safe and ask the hospital for copies of your records. Write down dates as you remember them, and do not alter or discard anything.

Filing Deadlines

Filing deadlines are set by state law. They vary with where you live and when the injury and its link to the device became known. Missing a filing deadline can end your claim, however strong the facts are. If you think a NeuroBlate procedure injured you, ask a lawyer about your deadline soon.

Potential Compensation

In a device injury claim, damages can include medical bills, lost income, pain and suffering and long-term care needs. Past verdicts and settlements say nothing about other claims. Monteris settled with Brassloff, and a Philadelphia jury later set a verdict in the case against the neurosurgeon, the university and Monteris. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation depends on the facts of the claim.

Frequently Asked Questions

When Did Monteris Learn About NeuroBlate Probe Heating?

Monteris first learned of NeuroBlate probe tip heating in August 2016, according to Medical Design and Outsourcing. A second case surfaced in December 2016, and two more came shortly before Monteris alerted the FDA in September 2017.

Could a NeuroBlate Probe Leak Cooling Gas into the Brain?

A NeuroBlate probe could let its carbon dioxide cooling gas leak into the brain, according to the FDA safety communication reported by Medscape. The FDA said the probe damage could also cause unanticipated heating of surrounding brain tissue.

What Does the Research Say About Treating Patients with NeuroBlate?

The research on treating patients with NeuroBlate comes from the FDA, which told providers to strongly consider alternative procedures until mitigation is evaluated. It added that providers who see no viable alternative should use the device with extreme caution.

Did Monteris Change the NeuroBlate Probe After the Recall?

Monteris did change the NeuroBlate probe after the recall, and MedTech Dive reports that the redesign cleared by the FDA is “designed to eliminate the unintended heating problem that triggered a Class I recall.”

References

1. https://www.inquirer.com/news/philly-medical-malpractice-monteris-neuroblate-brassloff-jury-award-20211112.html
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159161
3. https://www.law.com/thelegalintelligencer/2020/02/26/surgical-instrument-company-agrees-to-pay-brain-injured-man-12-75m-in-defective-equipment-lawsuit/
4. https://www.medtechdive.com/news/monteris-modifies-brain-ablation-device-to-counter-safety-risk/541844/
5. https://www.medscape.com/viewarticle/894342
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145141
7. https://www.mpo-mag.com/breaking-news/monteris-medical-neuroblate-system-recalled-over-unexpected-laser-delivery-probe-heating/
8. https://www.medicaldesignandoutsourcing.com/monteris-medical-recall-ceo/