Z-1614-2016Class I

NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01...

Name: Z-1614-2016 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01...
Creator: Monteris Medical Corp
Published: 2016-03-25
License: https://open.fda.gov/license/

Monteris Medical Corp / initiated 2016-03-25 / Terminated / root cause: design

FDA source

Monteris Medical Corp began a recall of 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... on 2016-03-25. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1614-2016
Classification: Class I
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-05-16
Terminated: 2017-03-10
Recalling firm: Monteris Medical Corp
Product: 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 code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes.
Quantity in commerce: 121
Distribution: Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
Product codes and lots: All unexpired lots of these models are being removed from the market.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1614-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16

Product code GEX

K143457Class IINeuroBlate SystemMonteris Medical, Inc. / cleared 2015-02-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)