Device recall
Z-2638-2025: Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-2638-2025 |
|---|---|
| Recall event | 97312 |
| Product | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically… |
| Product code | GEI |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160754, K211806, K250068 |
| FEI number | 2020394 |
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