Device recall
Z-1095-2014: CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02…
FDA device recall · Class III · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1095-2014 |
|---|---|
| Recall event | 67445 |
| Product | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely… |
| Product code | MCX |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 5, 2014 |
| 510(k) numbers | K071073 |
| 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