NeuroBlate System SideFire Select 2.2 mm Directional Laser… recallZ-1614-2016 · Monteris Medical Corp · initiated Mar 25, 2016
Class I Terminated All recalls posted in May 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Monteris Medical Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1614-2016
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Mar 25, 2016
- Posted by the FDA
- May 16, 2016
- Recalling firm
- Monteris Medical Corp
- Quantity
- 121
- Product code
- GEX
- FDA submissions
- K143457
- Distribution
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
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.
Code information (models, lots, serial numbers)
All unexpired lots of these models are being removed from the market.
Other devices under the same FDA submission
1 device cleared under K143457 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FullFire® Select Diffusing Tip Laser Probe 20624-00Monteris Medical Inc · Powered Laser Surgical Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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