Device recall
Z-0146-2023: Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0146-2023 |
|---|---|
| Recall event | 90905 |
| Product | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP |
| Product code | DXE |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193379 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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