Class II — Potential Health Hazard

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...

Date: October 3, 2014
Company: Monteris Medical Corp
Status: Terminated
Source: FDA (Device)

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

Affected (12 states)Not affected

About Monteris Medical Corp

Monteris Medical Corp has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report