Device recall
Z-1253-2024: The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible…
FDA device recall · Class II · Micro Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-1253-2024 |
|---|---|
| Recall event | 93922 |
| Product | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the… |
| Product code | MFE |
| Recalling firm | Micro Therapeutics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000220862 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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