Plymouth, MN, United States
Monteris Medical Corp recalls
1 recall recorded since 2018, most recently on 5 October 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 5 October 2017
- Terminated
- 21 January 2021
- Reason
- The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
- Distribution
- Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0194-2018
- MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.