Device recall
Z-2614-2025: Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal…
FDA device recall · Class I · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-2614-2025 |
|---|---|
| Recall event | 97496 |
| Product | Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous… |
| Product code | OWQ |
| Recalling firm | Medline Industries, LP |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K234064 |
| FEI number | 1417592 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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