Visual-ICE MRI Cryoablation System Mobile Connection Panel — Class II medical device recall Z-0287-2021
Terminated recall by Boston Scientific Corporation, reported 2020-11-04, distributed nationwide. Incorrectly installed base.
| Recall number | Z-0287-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-09-22 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2021-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Serial numbers | VM031 |
Product
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
Reason for recall
Incorrectly installed base.
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-0287-2021. 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.