Device recall
Z-1403-2020: MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular…
FDA device recall · Class II · Microvention, Inc.
Key facts
| Recall number (Z-number) | Z-1403-2020 |
|---|---|
| Recall event | 84727 |
| Product | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels… |
| Product code | HCG |
| Recalling firm | Microvention, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2022 |
| 510(k) numbers | K050954, K090357, 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