Device recall
Z-0653-2010: Edwards Lifesciences Aquarius System Model GEF09800.
FDA device recall · Class I · Edwards Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-0653-2010 |
|---|---|
| Recall event | 53554 |
| Product | Edwards Lifesciences Aquarius System Model GEF09800. |
| Product code | KDI |
| Recalling firm | Edwards Lifesciences, Llc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 18, 2012 |
| 510(k) numbers | K070320 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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