Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets
Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could prevent saline flow, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is recalling Visualase Cooled Laser Applicator System (VCLAS) Tubing Set kits. The affected product numbers are VCLAS 9735559, VCLAS 9735560, and VCLAS 9735561. The recall covers 4,654 units with lot numbers ranging from 0211041602 through 0217695790.
The firm received complaints regarding the saline tubing, specifically citing incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion. These defects could result in the disruption or prevention of saline flow.
The products were distributed in the United States and in France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, and the UK. Users should stop using the affected tubing sets and contact Medtronic for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 4,654
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All kits with lot numbers from 0211041602 through 0217695790
Distribution
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