Device recall
Z-1993-2013: Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is…
FDA device recall · Class II · Cardiogenesis Corporation
Key facts
| Recall number (Z-number) | Z-1993-2013 |
|---|---|
| Recall event | 66046 |
| Product | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a… |
| Product code | MNO |
| Recalling firm | Cardiogenesis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2014 |
| FEI number | 3001451326 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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