The Recall Desk
ModerateFDA (Devices)·Z-0287-2021·Announced 2020-11-04

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.

What this means for you

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
Category
Medical Device — Cryoablation System
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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