Device recall
Z-2045-2015: ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map…
FDA device recall · Class II · Volcano Corp
Key facts
| Recall number (Z-number) | Z-2045-2015 |
|---|---|
| Recall event | 71404 |
| Product | ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures. |
| Product code | IYO |
| Recalling firm | Volcano Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2015 |
| 510(k) numbers | K082229 |
| FEI number | 3008363989 |
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