Visualase Cooled Laser Applicator System recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled…
Why was Visualase Cooled Laser Applicator System recalled?
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 120
- Distribution
- Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
- Recall date
- May 25, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)