Device recall
Z-1882-2019: Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement…
FDA device recall · Class II · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-1882-2019 |
|---|---|
| Recall event | 83038 |
| Product | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. |
| Product code | DYE |
| Recalling firm | Medtronic Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2020 |
| PMA numbers | P980043 |
| FEI number | 3001504994 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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