FDA DevicesClass II
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradis...
Published: April 8, 2026Recall ID: Z-1654-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Palo Alto |
| State | CA |
| Event id | 98365 |
| Address 1 | 1049 Elwell Ct |
| Code info | Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907 |
| Postal code | 94303-4308 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260129 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmReCor Medical Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.