Device recall
Z-1907-2024: FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-1907-2024 |
|---|---|
| Recall event | 94437 |
| Product | FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 |
| Product code | DQY |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153729 |
| FEI number | 3008853977 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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