Device recall
Z-0749-2010: RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot…
FDA device recall · Class II · Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Key facts
| Recall number (Z-number) | Z-0749-2010 |
|---|---|
| Recall event | 53607 |
| Product | RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization. |
| Product code | NIM |
| Recalling firm | Abbott Vascular-Cardiac Therapies dba Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2011 |
| PMA numbers | P040012 |
| FEI number | 2024168 |
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