NeuroBlate System SideFire Select 2 — Class I medical device recall Z-1614-2016
Terminated recall by Monteris Medical Corp, reported 2016-05-25, distributed nationwide. Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with res
| Recall number | Z-1614-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monteris Medical Corp, Plymouth, MN, United States |
| Recall initiated | 2016-03-25 |
| Classified | 2016-05-16 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 121 |
| Reason classes | device malfunction |
| Model numbers | SFS000-01, SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, SFS522-01 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.