Device recall
Z-1654-2026: Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise…
FDA device recall · Class II · ReCor Medical Inc.
Key facts
| Recall number (Z-number) | Z-1654-2026 |
|---|---|
| Recall event | 98365 |
| Product | Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation |
| Product code | QYI |
| Recalling firm | ReCor Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P220023 |
| FEI number | 3010024164 |
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