Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FullFire Diffusing Tip Laser Probe Recalled by Monteris Medical Corp Due to Monteris Medical received a complaint of a separation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Monteris Medical Corp directly.
Affected Products
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
Quantity: 133 devices
Why Was This Recalled?
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Where Was This Sold?
This product was distributed to 12 states: CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, VA
About Monteris Medical Corp
Monteris Medical Corp has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report