Device recall
Z-1178-2010: Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number…
FDA device recall · Class II · Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1178-2010 |
|---|---|
| Recall event | 53474 |
| Product | Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
| Product code | LIT |
| Recalling firm | Abbott Vascular-Cardiac Therapies dba Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2012 |
| 510(k) numbers | K072798 |
| FEI number | 2024168 |
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