FDA Adverse Event
Malfunction
Summary report: N
PARADISE ULTRASOUND RENAL DENERVATION SYSTEM
MDR report key: 24633334
·
Received March 18, 2026
Report
- Report Number
- 3010024164-2026-00001
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- February 12, 2026
- Report Date
- March 18, 2026
- Manufacturer
- RECOR MEDICAL, INC.
- Product Code
- QYI
- PMA / PMN Number
- P220023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
EVENT: EXPIRED DEVICE USED. EVENT DESCRIPTION: A PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2026 USING A PARADISE CATHETER THAT HAD EXPIRED ON 31 JAN 2026. THE PARADISE CATHETER WAS INSPECTED PRIOR TO USE AND THE PACKAGING AND SEAL WAS INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PROCEDURAL COMPLICATIONS OR PATIENT INJURY/HARM WAS REPORTED FOR THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695080 | PARADISE ULTRASOUND RENAL DENERVATION SYSTEM | ABLATION CATHETER RENAL DENERVATION | QYI | RECOR MEDICAL, INC. | M4181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |