Device recall
Z-0794-2017: OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to…
FDA device recall · Class II · Oscor, Inc.
Key facts
| Recall number (Z-number) | Z-0794-2017 |
|---|---|
| Recall event | 75785 |
| Product | OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. |
| Product code | DYB |
| Recalling firm | Oscor, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2019 |
| 510(k) numbers | K101497, K122958 |
| FEI number | 1035166 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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