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Use caution Medical device recall · FDA · Published September 22, 2020

Boston Scientific Visual-ICE MRI Cryoablation System Mobile Connection Panel Recall

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.

🇺🇸 FDA recall #Z-0287-2021Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Corporation300 Boston Scientific Way · Marlborough, MA 01752-1291
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/64234-boston-scientific-visual-ice-mri-cryoablation-system-mobile-connection-panel.

Source Summary by GovInfoNow · govinfonow.com/recall/64234-boston-scientific-visual-ice-mri-cryoablation-system-mobile-connection-panel · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0287-2021

Cite this page

“Boston Scientific Visual-ICE MRI Cryoablation System Mobile Connection Panel Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64234-boston-scientific-visual-ice-mri-cryoablation-system-mobile-connection-panel. Based on FDA recall #Z-0287-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0287-2021%22&limit=1).

Boston Scientific Corporation voluntarily recalled the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base, according to the FDA on September 22, 2020.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP)
  • Serial Number: VM031

The hazard

The recall addresses an incorrectly installed base on the computer-controlled system with a touch screen user interface.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls include the Imager II Angiographic Catheters Recall (August 24, 2026), the LUX-Dx Cardiac Monitor System Recall (August 6, 2026), and the StoneSmart Connect Console Power Adapters recall (July 22, 2026). Similar product recalls include the Canon Vantage Titan 3T MRI Systems Recall (December 19, 2025), the Canon Medical Vantage Galan 3T MRI Recall (December 19, 2025), and the I.T.S. Hand Locking Plates System recall (January 23, 2026).

How to tell if you have this one

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.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Installation

    Verify that the device is installed correctly according to the manufacturer's guidelines.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution including in the state of Rochester, MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 22, 202012. FDA classified it Class II: Oct 23, 202023. Published in FDA’s Enforcement Report: Nov 4, 202034. FDA terminated the recall: Sep 22, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0287-2021 (September 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0287-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA