Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1614-2016 — 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 Sys

U.S. FDA — Device Enforcement · United States · 2016-03-25 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1614-2016
Date of alert: 2016-03-25
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Monteris Medical Corp
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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