Recall Z-0244-2023— Medtronic Navigation, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2022-10-14. It names 3 FDA 510(k) clearances: K211269, K181859, K053087. Product: 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: Due to a defect in the outer pouch sterile seal.
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-14
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
3 on FDA's record- K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4)
- K181859 — Visualase Thermal Therapy System
- K053087 — VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.