Device recall
Z-1906-2011: Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured…
FDA device recall · Class I · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-1906-2011 |
|---|---|
| Recall event | 58175 |
| Product | Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as… |
| Product code | HCG |
| Recalling firm | Penumbra Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| 510(k) numbers | K103305 |
| FEI number | 3005168196 |
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