Device recall
Z-0765-2019: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage…
FDA device recall · Class I · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0765-2019 |
|---|---|
| Recall event | 81878 |
| Product | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution… |
| Product code | DYG |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 2, 2023 |
| 510(k) numbers | K160084 |
| 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