Device recall
Z-1290-2015: Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The…
FDA device recall · Class I · Cardiovascular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1290-2015 |
|---|---|
| Recall event | 70727 |
| Product | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. 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 calcified coronary artery lesions. |
| Product code | MCX |
| Recalling firm | Cardiovascular Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 26, 2016 |
| PMA numbers | P130005 |
| FEI number | 3004742232 |
At a glance
- None 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