Drug recall
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed…
FDA recall event 93922 · Class II · Micro Therapeutics, Inc.
Key facts
| Event ID | 93922 |
|---|---|
| Recall numbers | Z-1252-2024, Z-1253-2024 |
| Recalling firm | Micro Therapeutics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | European version of microcatheter were distributed within US which contain a different "Indications for Use". |
| Initiation date | Jan 11, 2024 |
| Report date | Mar 13, 2024 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 1000220862 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: