Device recall
Z-1301-2022: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx…
FDA device recall · Class III · Volcano Corp
Key facts
| Recall number (Z-number) | Z-1301-2022 |
|---|---|
| Recall event | 90252 |
| Product | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 |
| Product code | OBJ |
| Recalling firm | Volcano Corp |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K121273 |
| 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