Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Medical device recall Z-3251-2018. Published in FDA’s Enforcement Report on Oct 3, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 3, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 35 states named in where it went
- 161 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
161, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI #: 00643169655935, 00643169792890, 00643169905719, Serial #:071217-001 110317-001 110603.001 110720.01 110825.01 111103.01 120601-001 120711.01 120920.01 130507.01 130523.01 130703.01 132078 132084 132160 132189 132190 132230 142071…
Every code shown here, 1,593 characters
UDI #: 00643169655935, 00643169792890, 00643169905719, Serial #:071217-001 110317-001 110603.001 110720.01 110825.01 111103.01 120601-001 120711.01 120920.01 130507.01 130523.01 130703.01 132078 132084 132160 132189 132190 132230 142071 142286 142310 142351 142352 142769 142815 142858 150175 151308 151329 151394 151460 151597 151697 2UA9160WND 50610.001 80414.001 81215.001 90112.001 90515.01 90519.02 CCS40011 N06183105 N06187582 N06201398 N06201536 N06203635 N06205585 N06207497 N06208756 N06210356 N06211047 N06211282 N06218634 N06228349 N06233025 N06237425 N06241803 N06241804 N06241913 N06242904 N06245890 N06251476 N06253719 N06253740 N06259079 N06262594 N06263649 N06265357 N06267972 N06267973 N06267974 N06269032 N06269438 N06269439 N06270019 N06278606 N06278607 N06278608 N06278609 N06279636 N06289894 N06289895 N06289896 N06289897 N06303708 N06303710 N06303711 N06319401 N06319402 N06319403 N06319404 N06320401 N06320795 N06502349 N06502350 N06503495 N06503496 N06671901 N06671902 N06676031 N06676032 N06676033 N06685201 N06685202 N06685203 N06685204 N06685206 N06687250 N06687251 N06687252 N06687253 N06687254 N06688835 N06734368 N06734369 N06740305 N06757275 N06763190 N06764462 N06767959 N06768840 N06772396 N06774642 N06774643 N06774644 N06777604 N06781010 N06805982 N06805983 N06807016 N06807017 N06807018 N06807019 N07279689 N07279690 N07279692 N07279693 N07291034 N07291035 N07291036 N07291037 N07291038 N07300434 N07372598 N07385291 N07385292 N07389258 N07389259 N07389260 N07582374 N07582375 N07816044 N07816045 N07816046 N07400747 N07400744 100811-001 N07400746 N07400745
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 1, 2018.
- FDA classified it on Sep 26, 2018.
- FDA’s Enforcement Report published it on Oct 3, 2018.
- FDA terminated it on Feb 2, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Navigation, Inc., of Louisville, CO.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.