Device recall
Z-0927-2022: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary…
FDA device recall · Class I · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-0927-2022 |
|---|---|
| Recall event | 89754 |
| Product | Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. |
| Product code | NPV |
| Recalling firm | Medtronic Inc |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P200046 |
| 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