Device recall
Z-1116-2019: Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx…
FDA device recall · Class I · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1116-2019 |
|---|---|
| Recall event | 82455 |
| Product | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for… |
| Product code | DXF |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 1, 2023 |
| FEI number | 2015691 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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