CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report

Visualase Cooled Laser Applicator System recalled

Medtronic Navigation is recalling Visualase Cooled Laser Applicator System (Vclas) 9735560 . Core Fiber Tip product, distributed nationwide in the US. The recall was initiated on 14 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

Quantity recalled95 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0244-2023
FDA event ID: 91041
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Ongoing
Recall initiated: 14 Oct 2022
FDA classified: 17 Nov 2022
Reported: 23 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

14 Oct 2022	Recall initiated by company
17 Nov 2022	Classified by FDA	+34 days
23 Nov 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a defect in the outer pouch sterile seal

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

Where it was distributed

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.

Nationwide Arizona California Colorado District of Columbia Florida Illinois Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri New Hampshire New Jersey New York Ohio Pennsylvania Rhode Island Texas

Questions about this recall

Is Visualase Cooled Laser Applicator System (Vclas) 9735560 . Core Fiber Tip product recalled?

Yes. Medtronic Navigation recalled Visualase Cooled Laser Applicator System (Vclas) 9735560 . Core Fiber Tip product on 14 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0244-2023.

Why was it recalled?

Due to a defect in the outer pouch sterile seal

Which lots are affected?

Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Sterility	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 3.0 and 3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide

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