Device recall
Z-1075-04: The product is a stainless steel stent mounted on a PTA balloon delivery device…
FDA device recall · Class II · Orbus Medical Technologies Inc
Key facts
| Recall number (Z-number) | Z-1075-04 |
|---|---|
| Recall event | 29074 |
| Product | The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL… |
| Product code | MEW |
| Recalling firm | Orbus Medical Technologies Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2012 |
| 510(k) numbers | K023248 |
| FEI number | 3014148220 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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