Reported Nov 23, 2022 · Ongoing
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or…
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) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
- Lot codes and dates
- Product Number/CFN9735560
- UDI-DI Code00763000416430
- Lot Numbers
02243824030224779378022482452202248245230224824525022482476702248247680224824769
- Amount recalled
- 95 units
Where it was sold
Why it was recalled
Due to a defect in the outer pouch sterile seal
This product could cause temporary or reversible health problems — stop using it.
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