Device recall
Z-2023-2012: EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118…
FDA device recall · Class II · EKOS Corporation
Key facts
| Recall number (Z-number) | Z-2023-2012 |
|---|---|
| Recall event | 62020 |
| Product | 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 infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It… |
| Product code | KRA |
| Recalling firm | EKOS Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2012 |
| 510(k) numbers | K081467, K111705 |
| FEI number | 3001627457 |
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