Device recall
Z-1290-2024: CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1290-2024 |
|---|---|
| Recall event | 94014 |
| Product | CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or… |
| Product code | DYB |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170997 |
| FEI number | 3013300026 |
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