Boston Scientific Recalls Visual-ICE MRI Cryoablation System Mobile Connection Panel
Boston Scientific is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries or illnesses, and the defect is a mechanical installation issue rather than a high-risk pathogen or structural failure leading to severe injury.
Plain-English summary
Boston Scientific Corporation is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP). The recall is being conducted because the product has an incorrectly installed base.
The affected unit has serial number VM031. The product was distributed nationwide in the United States, including in Rochester, Minnesota. The Visual-ICE MRI MCP is a computer-controlled system with a touch screen user interface used to control and monitor cryoablation procedures.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: VM031
Distribution
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