Monteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture
Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classifies this as an FDA Class I recall, and the source text describes a serious injury involving the introduction of CO2 into a patient's brain, meeting the criteria for a Critical severity score.
Plain-English summary
Monteris Medical Corp is voluntarily recalling 121 units of the NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. The affected models are SFS000-01, SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. These probes are part of the NeuroBlate System, which is indicated for use in neurosurgery to ablate, necrotize, or coagulate soft tissue using 1064 nm lasers under MRI visualization.
The recall was initiated after Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a Laser Interstitial Thermal Therapy (LITT) procedure. This fracture resulted in the introduction of CO2 into the patient's brain. The agency classifies this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected units were distributed nationwide in the states of Kansas, Missouri, North Carolina, Ohio, and Virginia. All unexpired lots of these models are being removed from the market. Healthcare facilities and consumers should stop using these specific probes immediately and contact Monteris Medical Corp for instructions on returning the devices.
The recalled product
- 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…
- Manufacturer
- Monteris Medical Corp
- Affected units
- 121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All unexpired lots of these models are being removed from the market.
Distribution
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