Device recall
Z-2718-2015: Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-2718-2015 |
|---|---|
| Recall event | 71881 |
| Product | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral… |
| Product code | PDU |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2016 |
| 510(k) numbers | K081804, K101777 |
| FEI number | 2939520 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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