Device recall
Z-1395-2020: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular…
FDA device recall · Class II · Microvention, Inc.
Key facts
| Recall number (Z-number) | Z-1395-2020 |
|---|---|
| Recall event | 84727 |
| Product | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product Usage: The MCS is also… |
| Product code | HCG |
| Recalling firm | Microvention, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2022 |
| 510(k) numbers | K050954, K091641, K131948, K132952, K153594 |
| 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