Boston Scientific recalls Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) due to risk of incorrect installation causing safety issues. Learn if your device is affected and what to do.
Incorrectly installed base.
Boston Scientific is recalling the Visual-ICE MRI Cryo:ablation System Mobile Connection Panel (Visual-ICE MRI MCP) because it can be incorrectly installed, which may lead to safety risks. This recall affects medical devices used in MRI procedures.
The device can be incorrectly installed, which may lead to safety risks during MRI procedures. This incorrect installation could potentially cause harm to patients or healthcare providers during the procedure.
Healthcare professionals using the Visual-ICE MRI Cryoablation System Mobile Connection Panel for MRI procedures are most at risk. Patients undergoing these procedures may also be affected if the device is improperly installed.
Check for the Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) with serial number VM031. This device is used in MRI procedures and is computer-controlled with a touch screen interface.
Verify that the device is installed correctly according to the manufacturer's guidelines.
The device may be unsafe if incorrectly installed, so it's important to check the installation before use.
Look for the Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) with serial number VM031.
Check that the device is installed correctly. If unsure, contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0287-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0287-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.