Device recall
Z-1844-2015: Volcano PV.035 Catheter: Part number: 88901; Product Usage: The Volcano PV.035…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1844-2015 |
|---|---|
| Recall event | 71537 |
| Product | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic… |
| Product code | OBJ |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2015 |
| 510(k) numbers | K121273 |
| FEI number | 2939520 |
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