Device recall
Z-1449-2020: Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to…
FDA device recall · Class II · Medtronic CoreValve LLC
Key facts
| Recall number (Z-number) | Z-1449-2020 |
|---|---|
| Recall event | 84837 |
| Product | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures. |
| Product code | DTI |
| Recalling firm | Medtronic CoreValve LLC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2025587 |
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