Device recall
Z-2613-2025: Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood…
FDA device recall · Class I · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-2613-2025 |
|---|---|
| Recall event | 97496 |
| Product | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH |
| Product code | OWQ |
| Recalling firm | Medline Industries, LP |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K232130 |
| 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