Device recall
Z-1198-2019: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding…
FDA device recall · Class III · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1198-2019 |
|---|---|
| Recall event | 82481 |
| Product | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. |
| Product code | DQY |
| Recalling firm | Cordis Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 3, 2021 |
| 510(k) numbers | K021593, K143412, K963962, K972978, K992673 |
| FEI number | 1016427 |
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