Device recall
Z-1689-2023: The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants…
FDA device recall · Class II · Bolton Medical Inc.
Key facts
| Recall number (Z-number) | Z-1689-2023 |
|---|---|
| Recall event | 92252 |
| Product | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is… |
| Product code | MIH |
| Recalling firm | Bolton Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P190015 |
| FEI number | 1000135961 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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