Device recall
Z-0905-2014: Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number…
FDA device recall · Class II · Medtronic Advanced Energy, LLC
Key facts
| Recall number (Z-number) | Z-0905-2014 |
|---|---|
| Recall event | 66835 |
| Product | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented… |
| Product code | GEI |
| Recalling firm | Medtronic Advanced Energy, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2014 |
| 510(k) numbers | K111285 |
| FEI number | 1000517638 |
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