Use caution Medical device recall · FDA · Published June 1, 2018

Medtronic Visualase Software Versions 3.1.1-3.2: MRI Guidance Inaccuracy Risk

Medtronic recalls Visualase software versions 3.1.1-3.2 for potential MRI-guided laser ablation inaccuracies that could spread thermal energy to surrounding tissue.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3251-2018Medical device Medtronic ›

Use caution until it’s fixed

Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling specific versions of its Visualase software (3.1.1 to 3.2) because MRI-guided laser treatments might spread heat to healthy tissue. This could cause unintended tissue damage during procedures. Read more at govinfonow.com/recall/70917-medtronic-visualase-software-versions-3-1-1-3-2-mri.

Source Summary by GovInfoNow · govinfonow.com/recall/70917-medtronic-visualase-software-versions-3-1-1-3-2-mri · Updated August 21, 2026 · FDA enforcement record: FDA #Z-3251-2018

Cite this page

“Medtronic Visualase Software Versions 3.1.1-3.2: MRI Guidance Inaccuracy Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70917-medtronic-visualase-software-versions-3-1-1-3-2-mri. Based on FDA recall #Z-3251-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3251-2018%22&limit=1).

The FDA announced on June 1, 2018, that Medtronic Navigation, Inc. is recalling the Visualase Thermal Therapy System and associated software due to potential inaccuracy during MRI-guided laser ablation procedures. The agency stated the issue may result in unaccounted spread of thermal energy to surrounding tissue.

How to tell if you have it

Brand: Medtronic
Product: Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2
Product #: 9735542
Units affected: 161

The hazard

According to the FDA, inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has had 25 other recalls on record since June 7, 2017. Other recent recalls include Medtronic PIN surgical pins that may not fit patient reference frames (Dec. 4, 2024), Medtronic StealthStation S8 App software issues causing flipped images or missing warnings (Aug. 22, 2024), and Medtronic Stealth S8 Software potentially showing missing digits during neurosurgery (March 26, 2024). Other recent recalls of similar products include I.T.S. DUL/UOL Systems Risk MRI Heating (Jan. 23, 2026), I.T.S. Olecranonplate with Angular Stability: MRI Safety Risk (Jan. 23, 2026), and I.T.S. GmbH Pelvic Reconstruction System: MRI Safety Risk (Jan. 23, 2026).

How to tell if you have this one

Check for software versions 3.1.1 to 3.2 on the Visualase Thermal Therapy System. Product numbers include 9735542 and specific serial numbers listed in the recall notice.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Visualase software version by checking the device settings or documentation.
Contact Medtronic
Reach out to Medtronic directly for assistance with the recall or to confirm if your software is affected.

Where it went and when

Where it was distributed

Distributed in 34 states and D.C., and outside the U.S.

FDA distribution: “U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

Jun 1, 2018Firm started the recall
Sep 26, 2018FDA classified it Class II
Oct 3, 2018Published in FDA’s Enforcement Report
Feb 2, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/70917-medtronic-visualase-software-versions-3-1-1-3-2-mri">Medtronic Visualase Software Versions 3.1.1-3.2: MRI Guidance Inaccuracy Risk (GovInfoNow)</a>

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-3251-2018 (June 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3251-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.