Device recall
Z-0851-2021: Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device +…
FDA device recall · Class I · Penumbra Inc.
Key facts
| Recall number (Z-number) | Z-0851-2021 |
|---|---|
| Recall event | 86989 |
| Product | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 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… |
| 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