Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Melting Risk
Medtronic is recalling 120 Visualase Cooled Laser Applicator Systems because the catheters may melt during procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (melting during procedure) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Navigation, Inc. is recalling 120 units of the Visualase Cooled Laser Applicator System (VCLAS). The recall covers specific model numbers (T03, T10, and T15) manufactured by BioTex. The VCLAS system consists of a Laser Diffusing Fiber (LDF) and a Cooled Catheter System (CCS) used to necrotize or coagulate soft tissue in various surgical procedures.
The recall was initiated because the catheters have the potential to melt during procedures. This defect could compromise the device's function and safety during use.
The affected devices were distributed within the US, Netherlands, Canada, and Australia, as well as to government, VA, and military consignees. Users should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 120
Distribution
Distribution scope not specified by the agency.
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