Device recall
Z-1869-2010: Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1869-2010 |
|---|---|
| Recall event | 55784 |
| Product | Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12. Catalog Number M00513860. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and… |
| Product code | ESW |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2011 |
| 510(k) numbers | K032930 |
| FEI number | 3005099803 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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