Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SideFire Directional 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
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. 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: 234 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