Drug recall
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI…
FDA recall event 85424 · Class II · INARI MEDICAL
Key facts
| Event ID | 85424 |
|---|---|
| Recall numbers | Z-2299-2020 |
| Recalling firm | INARI MEDICAL |
| Product type | Devices |
| Products | Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device… |
| Initiation date | Mar 23, 2020 |
| Report date | Jun 17, 2020 |
| Termination date | Aug 13, 2021 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3011525976 |
At a glance
- 1–9 Products in this recall
- 1–9 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: