Recall Z-0244-2023 ยท ONO Neurosurgical Laser With Mr Thermography
Medtronic Navigation, Inc.
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.
| Date | Nov 17, 2022 (initiated Oct 14, 2022) |
| Status | Open, Classified |
| Reason | Due to a defect in the outer pouch sterile seal |
| Root cause | Nonconforming Material/Component |
| Action | On 10/03/2022, the firm verbally notified affected customers and on 10/14/2022 sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customer informing them that Medtronic identified a breach to the sterile barrier of the outer pouch of specific lots of VCLAS 9735560 .4MM Core Fiber 10MM Tip products. Customer are instructed to: immediately identify and segregate affected products within your inventory. Medtronic will contact you to facilitate product replacement when unaffected product is available. Medtronic has determined that the inner pouches maintain sterility, accordingly, you may use |
| Quantity | 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. |
| FDA record | Open on fda.gov |