Device recall
Z-1152-2010: Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System…
FDA device recall · Class II · Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1152-2010 |
|---|---|
| Recall event | 53477 |
| Product | Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy… |
| Product code | NIM |
| Recalling firm | Abbott Vascular-Cardiac Therapies dba Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2012 |
| 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