Device recall
Z-2049-2009: Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System…
FDA device recall · Class I · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-2049-2009 |
|---|---|
| Recall event | 52963 |
| Product | Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. |
| Product code | DQY |
| Recalling firm | Penumbra Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 5, 2011 |
| 510(k) numbers | K083125 |
| 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