Boston Scientific Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Serial Number: VM031
Products Sold
Serial Number: VM031
Boston Scientific Corporation is recalling Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The due to Incorrectly installed base.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrectly installed base.
Recommended Action
Per FDA guidance
On 9/22/2020 the firm sent its consignee a letter. Accounts are not asked to return the affected product to BSC. The customer notification letter will notify the affected customer that the Visual-ICE MRI MCP unit will be corrected, and accounts are asked to complete an Acknowledgment Form indicating they have received the customer notification and are scheduling the field correction activities.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026