Device recall
Z-0939-2009: VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for…
FDA device recall · Class II · Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0939-2009 |
|---|---|
| Recall event | 50192 |
| Product | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for… |
| Product code | LOX |
| Recalling firm | Abbott Vascular-Cardiac Therapies dba Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2012 |
| PMA numbers | P810046, P810046S226 |
| FEI number | 2024168 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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