MONTERIS MEDICAL NEUROBLATE SYSTEM — Class I medical device recall Z-0194-2018
Terminated recall by Monteris Medical Corp, reported 2018-03-28, distributed nationwide. The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Te
| Recall number | Z-0194-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monteris Medical Corp, Plymouth, MN, United States |
| Recall initiated | 2017-10-05 |
| Classified | 2018-03-20 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2021-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 52 systems |
Product
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Reason for recall
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0194-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.