Device recall
Z-2313-2009: Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by…
FDA device recall · Class II · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-2313-2009 |
|---|---|
| Recall event | 52989 |
| Product | Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. |
| Product code | DQY |
| Recalling firm | Penumbra Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2010 |
| 510(k) numbers | K070970 |
| FEI number | 3005168196 |
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