Device recall
Z-0451-2022: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and…
FDA device recall · Class I · ev3 Inc.
Key facts
| Recall number (Z-number) | Z-0451-2022 |
|---|---|
| Recall event | 89229 |
| Product | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter… |
| Product code | MCW |
| Recalling firm | ev3 Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 2, 2024 |
| 510(k) numbers | K161361 |
| FEI number | 2183870 |
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