🔍 RecallPedia

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 therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2014 Monteris Medical Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    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, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11, 20368-1-C3462-12, 20368-1-C3462-13, 20368-1-C3462-14, 20368-1-C3462-16, 20368-1-C3462-17, 20368-1-C3462-18, 20368-1-C3462-19, 20368-1-C3462-22, 20368-1-C3462-24, 20368-1-C3462-25, 20368-1-C3756-01, 20368-1-C3756-02, 20368-1-C3756-04, 20368-1-C3756-05, 20368-1-C3756-06, 20368-1-C3756-07, 20368-1-C3756-08, 20368-1-C3756-11, 20368-1-C3756-12, 20368-2-C1276-02, 20368-2-C1276-04, 20368-2-C1276-05, 20368-2-C1276-06, 20368-2-C1276-07, 20368-2-C1276-08, 20368-2-C1276-09, 20368-2-C1276-11, 20368-2-C1276-12, 20368-2-C1276-13, 20368-2-C1276-14, 20368-2-C1276-15, 20368-2-C1276-16, 20368-2-C1276-17, 20368-2-C1276-18, 20368-2-C1276-19, 20368-2-C1276-20, 20368-2-C1276-21, 20368-2-C1276-22, 20368-2-C3287-01, 20368-2-C3287-02, 20368-2-C3287-03, 20368-2-C3287-04, 20368-2-C3287-05, 20368-2-C3287-06, 20368-2-C3287-07, 20368-2-C3287-08, 20368-2-C3287-09, 20368-2-C3287-10, 20368-2-C3287-11, 20368-2-C3287-12, 20368-2-C3287-13, 20368-2-C3287-14, 20368-2-C3287-15, 20368-2-C3287-16, 20368-2-C3287-17, 20368-2-C3287-19, 20368-2-C3287-20, 20368-2-C3287-21, 20368-2-C3287-22, 20368-2-C3472-01, 20368-2-C3472-02, 20368-2-C3472-03, 20368-2-C3472-04, 20368-2-C3472-05, 20368-2-C3472-06, 20368-2-C3472-07, 20368-2-C3472-08, 20368-2-C3472-09, 20368-2-C3472-10, 20368-2-C3472-11, 20368-3-C1115-01, 20368-3-C1115-02, 20368-3-C1115-03, 20368-3-C1115-04, 20368-3-C1115-05, 20368-3-C1115-06, 20368-3-C1115-07, 20368-3-C1115-08, 20368-3-C1115-09, 20368-3-C1115-10, 20368-3-C1116-01, 20368-3-C1116-02, 20368-3-C1116-04, 20368-3-C1116-05, 20368-3-C1116-06, 20368-3-C3293-01, 20368-3-C3293-02, 20368-3-C3293-03, 20368-3-C3293-04, 20368-3-C3293-05, 20368-3-C3293-07, 20368-3-C3293-10, 20368-3-C3293-11, 20368-3-C3293-13, 20368-3-C3293-14, 20368-3-C3293-15, 20368-3-C3293-16, 20368-3-C3293-17, 20368-3-C3293-19, 20368-3-C3293-20, 20368-3-C3293-21, 20368-3-C3293-23, 20368-3-C3452-04, 20368-3-C3452-06, 20368-3-C3452-07, 20368-3-C3452-09, 20368-3-C3452-10, 20368-3-C3452-11, 20368-3-C3452-13, 20368-3-C3452-14, 20368-3-C3452-15, 20368-3-C3452-17, 20368-3-C3452-18, 20368-3-C3452-20, 20368-3-C3452-21, 20368-3-C3452-22, 20368-3-C3452-24, 20368-3-C3452-25, 20368-3-C3512-01, 20368-3-C3512-02, 20368-3-C3512-03, 20368-3-C3512-04, 20368-3-C3512-05, 20368-3-C3512-06, 20368-3-C3512-08, 20368-4-C1117-01, 20368-4-C1117-02, 20368-4-C1117-03, 20368-4-C1117-05, 20368-4-C1117-06, 20368-4-C1117-08, 20368-4-C1117-09, 20368-4-C1117-10, 20368-4-C3166-01, 20368-4-C3166-02, 20368-4-C3166-03, 20368-4-C3166-04, 20368-4-C3166-05, 20368-4-C3166-06, 20368-4-C3166-07, 20368-4-C3166-08, 20368-4-C3166-09, 20368-4-C3166-10, 20368-4-C3166-12, 20368-4-C3166-13, 20368-4-C3166-14, 20368-4-C3166-15, 20368-4-C3166-16, 20368-4-C3166-17, 20368-4-C3166-18, 20368-4-C3166-19, 20368-4-C3166-20, 20368-4-C3264-01, 20368-4-C3264-02, 20368-4-C3264-03, 20368-4-C3264-04, 20368-4-C3264-06, 20368-4-C3264-08, 20368-4-C3264-09, 20368-4-C3264-10, 20368-4-C3264-12, 20368-4-C3264-14, 20368-4-C3264-15, 20368-4-C3264-16, 20368-4-C3264-17, 20368-4-C3264-18, 20368-4-C3264-19, 20368-4-C3264-21, 20368-4-C3264-22, 20368-4-C3264-24, 20368-4-C3264-25, 20368-5-C1118-03, 20368-5-C1118-04, 20368-5-C1118-05, 20368-5-C3298-03, 20368-5-C3298-04, 20368-5-C3298-05, 20368-5-C3298-06, 20368-5-C3298-07, 20368-5-C3298-08, 20368-5-C3298-09, 20368-5-C3298-10, 20368-5-C3798-01, 20368-5-C3798-02, 20368-5-C3798-21, 20368-5-C3798-22.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Monteris Medical Corp
Reason for Recall:
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

Product Codes/Lot Numbers:

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, 20368-1-C3173-13, 20368-1-C3173-14, 20368-1-C3173-15, 20368-1-C3173-16, 20368-1-C3173-17, 20368-1-C3173-18, 20368-1-C3173-19, 20368-1-C3173-20, 20368-1-C3258-01, 20368-1-C3258-02, 20368-1-C3258-04, 20368-1-C3258-05, 20368-1-C3258-06, 20368-1-C3258-07, 20368-1-C3258-12, 20368-1-C3258-13, 20368-1-C3258-14, 20368-1-C3462-01, 20368-1-C3462-02, 20368-1-C3462-03, 20368-1-C3462-04, 20368-1-C3462-05, 20368-1-C3462-06, 20368-1-C3462-07, 20368-1-C3462-08, 20368-1-C3462-09, 20368-1-C3462-10, 20368-1-C3462-11, 20368-1-C3462-12, 20368-1-C3462-13, 20368-1-C3462-14, 20368-1-C3462-16, 20368-1-C3462-17, 20368-1-C3462-18, 20368-1-C3462-19, 20368-1-C3462-22, 20368-1-C3462-24, 20368-1-C3462-25, 20368-1-C3756-01, 20368-1-C3756-02, 20368-1-C3756-04, 20368-1-C3756-05, 20368-1-C3756-06, 20368-1-C3756-07, 20368-1-C3756-08, 20368-1-C3756-11, 20368-1-C3756-12, 20368-2-C1276-02, 20368-2-C1276-04, 20368-2-C1276-05, 20368-2-C1276-06, 20368-2-C1276-07, 20368-2-C1276-08, 20368-2-C1276-09, 20368-2-C1276-11, 20368-2-C1276-12, 20368-2-C1276-13, 20368-2-C1276-14, 20368-2-C1276-15, 20368-2-C1276-16, 20368-2-C1276-17, 20368-2-C1276-18, 20368-2-C1276-19, 20368-2-C1276-20, 20368-2-C1276-21, 20368-2-C1276-22, 20368-2-C3287-01, 20368-2-C3287-02, 20368-2-C3287-03, 20368-2-C3287-04, 20368-2-C3287-05, 20368-2-C3287-06, 20368-2-C3287-07, 20368-2-C3287-08, 20368-2-C3287-09, 20368-2-C3287-10, 20368-2-C3287-11, 20368-2-C3287-12, 20368-2-C3287-13, 20368-2-C3287-14, 20368-2-C3287-15, 20368-2-C3287-16, 20368-2-C3287-17, 20368-2-C3287-19, 20368-2-C3287-20, 20368-2-C3287-21, 20368-2-C3287-22, 20368-2-C3472-01, 20368-2-C3472-02, 20368-2-C3472-03, 20368-2-C3472-04, 20368-2-C3472-05, 20368-2-C3472-06, 20368-2-C3472-07, 20368-2-C3472-08, 20368-2-C3472-09, 20368-2-C3472-10, 20368-2-C3472-11, 20368-3-C1115-01, 20368-3-C1115-02, 20368-3-C1115-03, 20368-3-C1115-04, 20368-3-C1115-05, 20368-3-C1115-06, 20368-3-C1115-07, 20368-3-C1115-08, 20368-3-C1115-09, 20368-3-C1115-10, 20368-3-C1116-01, 20368-3-C1116-02, 20368-3-C1116-04, 20368-3-C1116-05, 20368-3-C1116-06, 20368-3-C3293-01, 20368-3-C3293-02, 20368-3-C3293-03, 20368-3-C3293-04, 20368-3-C3293-05, 20368-3-C3293-07, 20368-3-C3293-10, 20368-3-C3293-11, 20368-3-C3293-13, 20368-3-C3293-14, 20368-3-C3293-15, 20368-3-C3293-16, 20368-3-C3293-17, 20368-3-C3293-19, 20368-3-C3293-20, 20368-3-C3293-21, 20368-3-C3293-23, 20368-3-C3452-04, 20368-3-C3452-06, 20368-3-C3452-07, 20368-3-C3452-09, 20368-3-C3452-10, 20368-3-C3452-11, 20368-3-C3452-13, 20368-3-C3452-14, 20368-3-C3452-15, 20368-3-C3452-17, 20368-3-C3452-18, 20368-3-C3452-20, 20368-3-C3452-21, 20368-3-C3452-22, 20368-3-C3452-24, 20368-3-C3452-25, 20368-3-C3512-01, 20368-3-C3512-02, 20368-3-C3512-03, 20368-3-C3512-04, 20368-3-C3512-05, 20368-3-C3512-06, 20368-3-C3512-08, 20368-4-C1117-01, 20368-4-C1117-02, 20368-4-C1117-03, 20368-4-C1117-05, 20368-4-C1117-06, 20368-4-C1117-08, 20368-4-C1117-09, 20368-4-C1117-10, 20368-4-C3166-01, 20368-4-C3166-02, 20368-4-C3166-03, 20368-4-C3166-04, 20368-4-C3166-05, 20368-4-C3166-06, 20368-4-C3166-07, 20368-4-C3166-08, 20368-4-C3166-09, 20368-4-C3166-10, 20368-4-C3166-12, 20368-4-C3166-13, 20368-4-C3166-14, 20368-4-C3166-15, 20368-4-C3166-16, 20368-4-C3166-17, 20368-4-C3166-18, 20368-4-C3166-19, 20368-4-C3166-20, 20368-4-C3264-01, 20368-4-C3264-02, 20368-4-C3264-03, 20368-4-C3264-04, 20368-4-C3264-06, 20368-4-C3264-08, 20368-4-C3264-09, 20368-4-C3264-10, 20368-4-C3264-12, 20368-4-C3264-14, 20368-4-C3264-15, 20368-4-C3264-16, 20368-4-C3264-17, 20368-4-C3264-18, 20368-4-C3264-19, 20368-4-C3264-21, 20368-4-C3264-22, 20368-4-C3264-24, 20368-4-C3264-25, 20368-5-C1118-03, 20368-5-C1118-04, 20368-5-C1118-05, 20368-5-C3298-03, 20368-5-C3298-04, 20368-5-C3298-05, 20368-5-C3298-06, 20368-5-C3298-07, 20368-5-C3298-08, 20368-5-C3298-09, 20368-5-C3298-10, 20368-5-C3798-01, 20368-5-C3798-02, 20368-5-C3798-21, 20368-5-C3798-22.

Distribution:

Distributed in: US, CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0227-2015

Related Recalls

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.

Monteris Medical

Class I - Dangerous

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.

Mar 25, 2016 Diagnostic Equipment Nationwide View Details →

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 therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

Monteris Medical

Class I - Dangerous

Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Oct 3, 2014 Infusion Pumps View Details →