Device recall
Z-2386-2021: STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM…
FDA device recall · Class II · Cardiovascular Systems Inc
Key facts
| Recall number (Z-number) | Z-2386-2021 |
|---|---|
| Recall event | 88388 |
| Product | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2026 |
| 510(k) numbers | K190634 |
| FEI number | 3004742232 |
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