FDAFDA · Food and drugs·Recall number 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 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.
Published May 25, 2016 · Recall initiated: March 25, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Monteris Medical Corp
- Distributor
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
- Lot
- All unexpired lots of these models are being removed from the market.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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