Device recall
Z-1752-2008: PT-3B Control Unit - component of the EndoWave Infusion Catheter System…
FDA device recall · Class II · EKOS Corporation
Key facts
| Recall number (Z-number) | Z-1752-2008 |
|---|---|
| Recall event | 47245 |
| Product | PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B… |
| Product code | KRA |
| Recalling firm | EKOS Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2011 |
| 510(k) numbers | K072507 |
| 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