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Lower risk Medical device recall · FDA · Published March 23, 2018

Medtronic Visualase Cooled Laser Applicator System Recall: Low Laser Energy Risk

Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips due to potential low laser energy output from untested fibers, which could cause fiber burnout at lower wattage.

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

🇺🇸 FDA recall #Z-2501-2018Medical deviceMedtronic ›
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Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710
✎ GovInfoNow plain-language explainer

Medtronic is recalling specific models of their Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips because certain batches were not tested at intended laser power levels. This could lead to the laser fibers producing less energy than expected, potentially causing burnout at lower wattage during medical procedures. Read more at govinfonow.com/recall/71637-medtronic-visualase-cooled-laser-applicator-system-recall-low-laser-energy.

Source Summary by GovInfoNow · govinfonow.com/recall/71637-medtronic-visualase-cooled-laser-applicator-system-recall-low-laser-energy · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2501-2018

Cite this page

“Medtronic Visualase Cooled Laser Applicator System Recall: Low Laser Energy Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71637-medtronic-visualase-cooled-laser-applicator-system-recall-low-laser-energy. Based on FDA recall #Z-2501-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2501-2018%22&limit=1).

The FDA announced on March 23, 2018, that Medtronic Navigation, Inc. is recalling Visualase Cooled Laser Applicator Systems due to potential low laser energy output or fiber burnout. The recall affects 1,283 devices distributed worldwide.

How to tell if you have it

  • Brand: Medtronic
  • Product: Visualase Cooled Laser Applicator System (VCLAS)
  • Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip
  • Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip
  • Part Number 9735561 Visualase Cooled Laser Applicator System 15mm Tip

The hazard

Certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels due to a calibration issue with test equipment. This defect can lead to the potential for low laser energy output from the fiber or fiber burnout at lower wattage.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since June 7, 2017. Recent brand recalls include issues with PIN surgical pins not fitting patient reference frames reported on Dec. 4, 2024, and software anomalies causing flipped images or missing warnings in StealthStation S8 App versions 1.3.0 and 1.3.2 reported on Aug. 22, 2024. Other recent recalls of similar products include the Lutronic DermaV Laser System recall for risk of patient burn during treatment (Aug. 6, 2026), the Diowave Laser System recall requiring a software update for safety (Jan. 9, 2026), and the Lutronic CLARITY II Laser System Model 1110200210 recall for sparks and potential patient burns (Jan. 27, 2026).

How to tell if you have this one

Check for part numbers 9735559 (3mm tip), 9735560 (10mm tip), or 9735561 (15mm tip) with the listed lot codes and UDI numbers provided in the recall notice.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the product's part number and lot codes to confirm if it matches the recalled models listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 31 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. International distribution to Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, 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 5.4 years after the firm started it.

1. Firm started the recall: Mar 23, 201812. FDA classified it Class II: Jul 19, 201823. Published in FDA’s Enforcement Report: Jul 25, 201834. FDA terminated the recall: Jul 31, 2023420182023
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this product immediately?

No immediate stop is required as the hazard is low risk. However, you should check your product details against the recall list to confirm if it is affected.

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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-2501-2018 (March 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2501-2018 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.
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