Use caution Medical device recall · FDA · Published July 8, 2019

Medtronic Visualase Cooled Laser Tubing Kits: Saline Flow Risk

Medtronic recalls Visualase Cooled Laser Applicator System Tubing Sets with specific product numbers and lot ranges due to potential saline flow disruption from incorrect fittings or adhesive.

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

🇺🇸 FDA recall #Z-1905-2020Medical device Medtronic ›

Use caution until it’s fixed

The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Medtronic is recalling Visualase Cooled Laser Applicator System Tubing Sets that may have incorrect Luer connectors, drip chambers, or excessive adhesive. This could block saline flow during medical procedures, risking procedure failure or complications. Read more at govinfonow.com/recall/67472-medtronic-visualase-cooled-laser-tubing-kits-saline-flow-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67472-medtronic-visualase-cooled-laser-tubing-kits-saline-flow-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1905-2020

Cite this page

“Medtronic Visualase Cooled Laser Tubing Kits: Saline Flow Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67472-medtronic-visualase-cooled-laser-tubing-kits-saline-flow-risk. Based on FDA recall #Z-1905-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1905-2020%22&limit=1).

The FDA announced on July 8, 2019, that Medtronic Navigation, Inc. is recalling Visualase Cooled Laser Applicator System Tubing Set kits due to potential saline flow disruption. The agency classified the recall as Class II.

How to tell if you have it

Brand: Medtronic
Product: Visualase Cooled Laser Applicator System Tubing Set kits
Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter; VCLAS 9735560, 10mm tip/1.65mm catheter; VCLAS 9735561, 15mm tip/1.85mm catheter
Lot numbers: 0211041602 through 0217695790
Units affected: 4654

The hazard

The firm received complaints regarding incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion. These defects could result in disruption or prevention of saline flow.

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 (Dec. 4, 2024), software anomalies causing flipped images in StealthStation S8 App versions 1.3.0 and 1.3.2 (Aug. 22, 2024), and missing digits during neurosurgery (March 26, 2024). Other recent recalls of similar products include Medline medical procedure kits with Strykeflow 2 irrigation leak risk (Dec. 16, 2025) and Medline Dialysis Kits Recall regarding silicone seal issues (Jan. 8, 2026).

How to tell if you have this one

Check for product numbers VCLAS 9735559, 9735560, or 9735561 with lot numbers from 0211041602 through 0217695790. These kits are used in laser surgery procedures.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Numbers
Identify if your kit has product numbers VCLAS 9735559, 9735560, or 9735561 with lot numbers in the specified range.

Where it went and when

Where it was distributed

Distributed in 36 states and D.C., and outside the U.S.

FDA distribution: “US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK” 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, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 5.3 years after the firm started it.

Jul 8, 2019Firm started the recall
May 5, 2020FDA classified it Class II
May 13, 2020Published in FDA’s Enforcement Report
Oct 16, 2024FDA 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 these kits immediately?

No immediate stop is required; check your product numbers and lot numbers to determine if your kit is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/67472-medtronic-visualase-cooled-laser-tubing-kits-saline-flow-risk">Medtronic Visualase Cooled Laser Tubing Kits: Saline Flow 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-1905-2020 (July 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1905-2020 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.