Device recall
Z-1392-2020: MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular…
FDA device recall · Class II · Microvention, Inc.
Key facts
| Recall number (Z-number) | Z-1392-2020 |
|---|---|
| Recall event | 84727 |
| Product | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V… |
| Product code | HCG |
| Recalling firm | Microvention, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2022 |
| 510(k) numbers | K050954, K091641, K132952, K153594, K161367 |
| FEI number | 3003523199 |
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