Device recall
Z-1959-2012: CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11…
FDA device recall · Class II · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1959-2012 |
|---|---|
| Recall event | 62406 |
| Product | CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a… |
| Product code | MCW |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2012 |
| 510(k) numbers | K110389 |
| 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