FDANews
The QMN Weekly Bulletin

Monteris Medical Initiates Recall of Laser Probe Used in NeuroBiate System

July 15, 2016

Monteris Medical initiated a nationwide recall of its SideFire Select 2.2 mm Directional Laser Probe, following reports of fracture that resulted in CO2 introduction in the brain.

FDA determined the device design was the reason for recalling 121 probes that are a part of the NeuroBiate system used during neurosurgery.

In late 2015, Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a procedure.

One of a devicemaker’s biggest headaches is handling a recall. Noted recall management specialist Pamela Furman Forest can ease your fears in just 10 minutes with our eLearning program Recall Management for Devicemakers by teaching your employees all they need to know about dealing with device recalls.

View today's stories