Device recall
Z-2442-2021: MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational…
FDA device recall · Class II · Mivi Neuroscience Inc
Key facts
| Recall number (Z-number) | Z-2442-2021 |
|---|---|
| Recall event | 88408 |
| Product | MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the… |
| Product code | DQY |
| Recalling firm | Mivi Neuroscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2024 |
| 510(k) numbers | K151396 |
| FEI number | 3011410509 |
At a glance
- 1–9 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