Device recall
Z-0849-2021: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF…
FDA device recall · Class I · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-0849-2021 |
|---|---|
| Recall event | 86989 |
| Product | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion… |
| Product code | NRY |
| Recalling firm | Penumbra Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 14, 2024 |
| 510(k) numbers | K190010, K191946, K202251 |
| 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