Device recall
Z-0528-2015: Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The…
FDA device recall · Class II · Concentric Medical Inc
Key facts
| Recall number (Z-number) | Z-0528-2015 |
|---|---|
| Recall event | 69799 |
| Product | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue… |
| Product code | NRY |
| Recalling firm | Concentric Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2014 |
| 510(k) numbers | K120961 |
| FEI number | 3003271051 |
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