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.
Reported: November 23, 2022 Initiated: October 14, 2022 #Z-0244-2023
Product Description
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.
Reason for Recall
Due to a defect in the outer pouch sterile seal
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 95 units
- Distribution
- U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Navigation, Inc.. Units affected: 95 units.
Why was this product recalled? ▼
Due to a defect in the outer pouch sterile seal
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0244-2023.
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