Device recall
Z-2370-2020: Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x…
FDA device recall · Class II · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-2370-2020 |
|---|---|
| Recall event | 85497 |
| Product | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, |
| Product code | NIQ |
| Recalling firm | Abbott Vascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2021 |
| FEI number | 2024168 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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