Device recall
Z-3331-2026: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra…
FDA device recall · Class II · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-3331-2026 |
|---|---|
| Recall event | 99591 |
| Product | Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1… |
| Product code | NRY |
| Recalling firm | Penumbra Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203440, K250690 |
| 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