Device recall
Z-0244-2023: Visualase Cooled Laser Applicator System (VCLAS) 9735560.4MM CORE FIBER 10MM…
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0244-2023 |
|---|---|
| Recall event | 91041 |
| 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. |
| Product code | ONO |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K053087 |
| FEI number | 1000517638 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database