MAUDE Adverse Event Report: RECOR MEDICAL, INC. PARADISE ULTRASOUND RENAL DENERVATION SYSTEM; ABLATION CATHETER RENAL DENERVATION

Lot Number	M5137, M5116
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event: renal artery dissection event description: a 66-year-old female underwent a urdn procedure on (b)(6) 2026.Pre-procedural angiogram and ivus identified an ostial abnormality in the right renal artery (rra) suspected to be fibromuscular dysplasia (fmd), a known contraindication of urdn procedure.However, despite this the physician decided to proceed with urdn procedure because as per physician potential benefits outweighed the risks for the patient.Procedure completed without any device malfunction.Post-procedure angiography of rra revealed slow flow, severe vasospasm, and a dissection at the location where no sonication was provided.Nitroglycerine was administered and a stent was subsequently placed in the proximal to mid rra.On (b)(6) 2026, same day as the procedure, the events were resolved and the patient was discharged from hospital.According to the treating physician, the fmd-affected segment got worsened probably due to potential deep seating of the medtronic 7f ima guide catheter or manipulation of the paradise catheter which could have led to the dissection.

• Brand Name: PARADISE ULTRASOUND RENAL DENERVATION SYSTEM
• Common Device Name: ABLATION CATHETER RENAL DENERVATION
• Manufacturer (Section D): RECOR MEDICAL, INC.; 1049 elwell court; palo alto CA 94303
• Manufacturer (Section G): RECOR MEDICAL, INC.; 1049 elwell court; palo alto CA 94303
• Manufacturer Contact: ankita joshi ; 1049 elwell court; palo alto, CA 94303
• MDR Report Key: 25846167
• Report Number: 3010024164-2026-00003
• Device Sequence Number: 10304667
• Product Code: QYI
• UDI-Device Identifier: 00810008950012
• UDI-Public: 00810008950012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: M5137, M5116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC 7F IMA GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female