The Recall Desk
HighFDA (Devices)·Z-0227-2015·Announced 2014-11-26

Monteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation

Monteris Medical is recalling 234 SideFire Directional Laser Probes because the distal sapphire tip may separate from the probe.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for brain therapy where a component separation could pose a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Monteris Medical Corp is recalling 234 SideFire Directional Laser Probes (REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01) due to a reported defect. The recall was initiated after the company received a complaint that the distal sapphire tip separated from the laser delivery probe. These probes are part of the NeuroBlate System, which uses MRI-compatible laser devices to deliver precision thermal therapy in the brain.

The affected devices were distributed in the United States, including the states of California, Connecticut, Florida, Georgia, Kansas, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. The recall covers specific serial numbers listed in the official FDA notice. No illnesses or injuries are reported in the source text.

Healthcare providers and consumers should stop using the affected laser probes immediately. Users should check their device serial numbers against the list provided by the FDA or Monteris Medical. For more information, contact the recalling firm or refer to the FDA recall notice Z-0227-2015.

The recalled product

Product
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therap
Manufacturer
Monteris Medical Corp
Category
Medical Device — Neurological / Laser Therapy
Hazard
Affected units
234

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 (20)

  • serial numbers: 20368-1-C1112-01
  • 20368-1-C1112-02
  • 20368-1-C1112-03
  • 20368-1-C1112-04
  • 20368-1-C1112-05
  • 20368-1-C1112-06
  • 20368-1-C1112-07
  • 20368-1-C1112-08
  • 20368-1-C1112-09
  • 20368-1-C3173-02
  • 20368-1-C3173-03
  • 20368-1-C3173-04
  • 20368-1-C3173-05
  • 20368-1-C3173-06
  • 20368-1-C3173-07
  • 20368-1-C3173-08
  • 20368-1-C3173-09
  • 20368-1-C3173-10
  • 20368-1-C3173-11
  • 20368-1-C3173-12

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 2 recalled by Monteris Medical Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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