When a surgeon performs brain surgery using the NeuroBlate System, it caused severe injury to patients. Manufactured by Monteris Medical, the NeuroBlate System uses laser ablation to perform procedures on the brain. This includes tumor removal. However, in some cases, the tip or part of the probe may break and causes carbon monoxide to release into the brain.
The NeuroBlate System combines a surgical laser, MRI imaging and software to remove, thicken, or destroy cells during minimally-invasive brain procedures. The system is intended to allow neurosurgeons to remove tumors and lesions that were once considered inoperable. The NeuroBlate Laser Delivery Probe is a small, carbon dioxide (CO2)-cooled catheter designed to allow minimally invasive entry into a patient’s brain.
In October 2017, Monteris Medical initiated a recall for certain NeuroBlate Laser Delivery Probes after the NeuroBlate can heat and damage the probe during procedures. The FDA later called for a Class I NeuroBlate recall. This indicates that the probe could cause serious injury or death. Between October and December 2017, Monteris issued three advisories regarding unintended probe tip heating.
Devices included in the recall include the following models 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)
There are over 50 probes in the recall. The recalled NeuroBlate Probes were manufactured from April 2013 to July 2017.
NeuroBlate Probe Brain Injury and Death Reports
According to an FDA letter to health care providers dated March 22, 2018, the issues that prompted the NeuroBlate Probe recall are an interaction between the thermocouple in the probe and the MRI environment. The interaction can damage the tip of the probe and release carbon dioxide into the brain. Also, the FDA received multiple reports of the device overheating including a report of a patient who died after experiencing an intracranial hemorrhage.
We Want to Help NeruoBlate Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or someone you love had brain surgery with a recalled NeuroBlate Probe, you should demand accountability. We want to also help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement may give you compensation for their injuries and damages. The types of recoverable losses are:
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if you or someone you love had brain surgery with a recalled NeuroBlate Probe, please speak to us to learn more about your rights.