Device recall
Z-1677-2022: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1677-2022 |
|---|---|
| Recall event | 90647 |
| Product | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. |
| Product code | DYB |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K170997 |
| FEI number | 3003113629 |
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