Device recall
Z-1775-2017: Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-1775-2017 |
|---|---|
| Recall event | 76885 |
| Product | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries… |
| Product code | OBJ |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K160583 |
| 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