The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0228-2015·Announced 2014-11-26

Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a structural failure (tip separation) of a medical device used in the brain, which presents a risk of harm even though specific injuries are not detailed in the provided text.

Plain-English summary

Monteris Medical Corp is recalling 133 units of the FullFire Diffusing Tip Laser Probe, reference numbers DTP101-01, DTP201-01, DTP301-01, DTP401-01, and DTP501-01. These laser probes are components of the NeuroBlate System, a collection of MRI-compatible laser devices used for precision thermal therapy in the brain. The recall was initiated after the company received a complaint regarding the separation of the distal sapphire tip from the laser delivery probe.

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. Specific serial numbers for the 133 affected units are listed in the official recall documentation.

Healthcare providers and consumers should stop using the affected laser probes immediately. Monteris Medical is the recalling firm responsible for managing the recall process.

The recalled product

Product
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. 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…
Manufacturer
Monteris Medical Corp
Category
Medical Device — Laser Probe
Hazard
Affected units
133

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: 20414-1-C1274-03
  • 20414-1-C1274-04
  • 20414-1-C1274-06
  • 20414-1-C1274-07
  • 20414-1-C1274-08
  • 20414-1-C1274-09
  • 20414-1-C1274-11
  • 20414-1-C1274-12
  • 20414-1-C1274-13
  • 20414-1-C1274-17
  • 20414-1-C1274-19
  • 20414-1-C1274-20
  • 20414-1-C1367-01
  • 20414-1-C1367-02
  • 20414-1-C1367-04
  • 20414-1-C1367-05
  • 20414-1-C1367-06
  • 20414-1-C1367-07
  • 20414-1-C3302-02
  • 20414-1-C3302-05

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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