Unrated Medical device recall · FDA · Published October 14, 2022

Medtronic Visualase Cooled Laser Applicator System Recall: Defective Sterile Seal

Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 with defective sterile seal that may compromise safety during surgery.

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

🇺🇸 FDA recall #Z-0244-2023Medical device Medtronic ›

Recall notice

Due to a defect in the outer pouch sterile seal

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Medtronic is recalling a specific laser surgical device due to a defect in its outer pouch sterile seal. This could potentially compromise the device's safety during medical procedures. Read more at govinfonow.com/recall/59914-medtronic-visualase-cooled-laser-applicator-system-recall-defective-sterile-seal.

Source Summary by GovInfoNow · govinfonow.com/recall/59914-medtronic-visualase-cooled-laser-applicator-system-recall-defective-sterile-seal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0244-2023

Cite this page

“Medtronic Visualase Cooled Laser Applicator System Recall: Defective Sterile Seal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59914-medtronic-visualase-cooled-laser-applicator-system-recall-defective-sterile-seal. Based on FDA recall #Z-0244-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0244-2023%22&limit=1).

The FDA announced on 2022-10-14 that Medtronic Navigation, Inc. is recalling the Visualase Cooled Laser Applicator System due to a defect in the outer pouch sterile seal. The recall affects 95 units distributed nationwide.

How to tell if you have it

Brand: Medtronic
Product: Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP
Product Number/CFN: 9735560
UDI-DI Code: 00763000416430
Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
Distribution: U.S. Nationwide including AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV

The hazard

The recall is due to a defect in the outer pouch sterile seal. The product is used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Recent issues include software anomalies causing flipped images or missing warnings in StealthStation S8 App versions 1.3.0 and 1.3.2 reported on 2024-08-22, and potential missing digits during neurosurgery noted on 2024-03-26. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (2026-04-21), Medtronic GUNDRY Cannula Recall (2026-04-21), and Medtronic DLP Cannula Recall (2026-04-21).

How to tell if you have this one

Check for product number 9735560 with lot numbers 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, or 0224824769. This device is used for necrotizing or coagulating soft tissue during surgery.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your device has product number 9735560 and one of the listed lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 22 states.

FDA distribution: “U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Illinois, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 40 days after the firm started it.

Oct 14, 2022Firm started the recall
Nov 17, 2022FDA classified it Class II
Nov 23, 2022Published in FDA’s Enforcement Report

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/59914-medtronic-visualase-cooled-laser-applicator-system-recall-defective-sterile-seal">Medtronic Visualase Cooled Laser Applicator System Recall: Defective Sterile Seal (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-0244-2023 (October 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0244-2023 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.