Ablation Catheter, Renal Denervation
FDA product code QYI · Class III (high risk) · Cardiovascular
For denervating the renal nerves to lower blood pressure
0510(k) clearances
2PMA approvals
2recalls
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1655-2026 Class II | Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter…Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | ReCor Medical Inc. | 01/29/2026Open, Classified |
| Z-1654-2026 Class II | Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter…Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | ReCor Medical Inc. | 01/29/2026Open, Classified |