Reported May 25, 2016 · Terminated
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- 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.
- Lot codes and dates
- All lot numbers manufactured by
- BioTex are affected for Model NumbersT03: 001-4003 - VCLAS 001-4003 .4mm
- CORE FIBER 3mm TIP T10001-4000 - VCLAS 001-4000 .4mm
- CORE FIBER 10mm TIP T15001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP
- Amount recalled
- 120
Where it was sold
Why it was recalled
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
This product could cause temporary or reversible health problems — stop using it.
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