Device recall
Z-1121-2025: MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5…
FDA device recall · Class II · MICROVENTION INC.
Key facts
| Recall number (Z-number) | Z-1121-2025 |
|---|---|
| Recall event | 96114 |
| Product | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked… |
| Product code | QCA |
| Recalling firm | MICROVENTION INC. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P170013 |
| FEI number | 3013556777 |
At a glance
- None 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