CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report

Visualase Cooled Laser Applicator System (Vclas) recalled

Medtronic Navigation is recalling Visualase Cooled Laser Applicator System (Vclas), distributed in Virginia. The recall was initiated on 9 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP

Quantity recalled120

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-1672-2016
FDA event ID: 74096
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Terminated
Recall initiated: 9 May 2016
FDA classified: 16 May 2016
Reported: 25 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

9 May 2016	Recall initiated by company
16 May 2016	Classified by FDA	+7 days
25 May 2016	Published in enforcement report	+9 days

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

Reason for recall

Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.

Where it was distributed

Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.

Virginia

Questions about this recall

Is Visualase Cooled Laser Applicator System (Vclas) recalled?

Yes. Medtronic Navigation recalled Visualase Cooled Laser Applicator System (Vclas) on 9 May 2016. The recall is Class II and its status is Terminated. Recall number Z-1672-2016.

Why was it recalled?

Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

Which lots are affected?

All lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP

Where was it sold?

Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.

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.

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