CLASS I Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Neuroblate System, used for Mri-guided neurosurgical ablation recalled
Monteris Medical is recalling Neuroblate System, used for Mri-guided neurosurgical ablation, distributed nationwide in the US. The recall was initiated on 5 Oct 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0194-2018
- FDA event ID
- 78315
- Recalling firm
- Monteris Medical, Plymouth, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Oct 2017
- FDA classified
- 20 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 5 Oct 2017 | Recall initiated by company | |
| 20 Mar 2018 | Classified by FDA | +166 days |
| 28 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Product as listed by the FDA
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Where it was distributed
Nationwide and Canada
Questions about this recall
Why was it recalled?
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Which lots are affected?
All serial numbers
Where was it sold?
Nationwide and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Monteris Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | NeuroBlate System SideFire Select Directional Laser Probe recalled | Monteris Medical | Other | Nationwide |
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| Device | CLASS II | FullFire Diffusing Tip Laser Probe recalled by Monteris Medical | Monteris Medical | Other | 12 states |
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