Drug recall
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140…
FDA recall event 62020 · Class II · EKOS Corporation
Key facts
| Event ID | 62020 |
|---|---|
| Recall numbers | Z-2023-2012 |
| Recalling firm | EKOS Corporation |
| Product type | Devices |
| Products | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report… |
| Initiation date | May 24, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Nov 20, 2012 |
| City | Bothell |
| State | WA |
| Country | United States |
| FEI number | 3001627457 |
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: