MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Product Codes/Lot Numbers:
All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0194-2018
Related Recalls
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.
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.