Monteris Medical Corp: Medical Device Recall in 2016 - (Recall #: Z-1614-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.

Product Classification:

Class I

Date Initiated: March 25, 2016

Date Posted: May 25, 2016

Recall Number: Z-1614-2016

Event ID: 73849

Reason for Recall:

Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.

Status: Terminated

Product Quantity: 121

Code Information:

All unexpired lots of these models are being removed from the market.

Distribution Pattern:

Nationwide Distribution in the states of KS, MO, NC, OH, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated