Device recall
Z-2221-2025: Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P…
FDA device recall · Class II · Volcano Corp
Key facts
| Recall number (Z-number) | Z-2221-2025 |
|---|---|
| Recall event | 97192 |
| Product | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use. |
| Product code | OBJ |
| Recalling firm | Volcano Corp |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150442, K152829 |
| 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