Device recall
Z-1614-2024: Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for…
FDA device recall · Class I · ROUTE 92 MEDICAL INC
Key facts
| Recall number (Z-number) | Z-1614-2024 |
|---|---|
| Recall event | 94270 |
| Product | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients. |
| Product code | DQY |
| Recalling firm | ROUTE 92 MEDICAL INC |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3016522967 |
At a glance
- None 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