CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Visual-ICE MRI Cryoablation System Mobile Connection Panel recalled
Boston Scientific is recalling Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP), distributed nationwide in the US. The recall was initiated on 22 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0287-2021
- FDA event ID
- 86539
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2020
- FDA classified
- 23 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 22 Sep 2020 | Recall initiated by company | |
| 23 Oct 2020 | Classified by FDA | +31 days |
| 4 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrectly installed base.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the state of Rochester, MN.
Questions about this recall
Is Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) recalled?
Yes. Boston Scientific recalled Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) on 22 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0287-2021.
Why was it recalled?
Incorrectly installed base.
Which lots are affected?
Serial Number: VM031
Where was it sold?
US Nationwide distribution including in the state of Rochester, MN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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