Medtronic Navigation, Inc. Recall 91041
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.
Medtronic Navigation, Inc. Recall 91041 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0244-2023 |
| Event ID | 91041 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 95 units |
| Recall Reason | Due to a defect in the outer pouch sterile seal |
| Device Classification | 20221123 |
| Device Code Info | Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769 |
| Center Classification Date | 20221117 |
| Recall Initiation Date | 20221014 |
| Recalling Firm | Medtronic Navigation, Inc. |
| Initial Notification | Letter |
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