Reported Nov 4, 2020 · Terminated

Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is…

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291

Is this the product you have?

  • Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE
  • MRI MCP) - Product UsageThe system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure
Lot codes and dates
  • Serial NumberVM031
Amount recalled
1 unit

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • MN

Why it was recalled

Incorrectly installed base.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 22, 2021 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.