Device recall
Z-2441-2021: MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm…
FDA device recall · Class II · Mivi Neuroscience Inc
Key facts
| Recall number (Z-number) | Z-2441-2021 |
|---|---|
| Recall event | 88408 |
| Product | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. 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