Device recall
Z-2702-2017: Penumbra 3D Revascularization Device It is indicated for used in the…
FDA device recall · Class I · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-2702-2017 |
|---|---|
| Recall event | 77571 |
| Product | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are… |
| Product code | NRY |
| Recalling firm | Penumbra Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 9, 2019 |
| 510(k) numbers | K162901 |
| 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