Device recall
Z-0727-2019: Visions PV.035 Digital IVUS Catheter, Catalog Number/Part Number…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-0727-2019 |
|---|---|
| Recall event | 81882 |
| Product | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that… |
| Product code | OBJ |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2021 |
| 510(k) numbers | K153094 |
| 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