Device recall
Z-0864-2011: Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F…
FDA device recall · Class II · Medtronic CardioVascular
Key facts
| Recall number (Z-number) | Z-0864-2011 |
|---|---|
| Recall event | 55541 |
| Product | Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide… |
| Product code | DQY |
| Recalling firm | Medtronic CardioVascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2011 |
| 510(k) numbers | K081804 |
| FEI number | 3001452571 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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