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

Lot Number	M4308, M4347, M4733
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event: renal artery thrombosis event description: a female patient underwent ultrasound renal denervation procedure on (b)(6) 2025.During the procedure, multiple attempts were made to access the challenging, tortuous left renal artery using three different paradise balloons, which repeatedly dislodged due to resistance caused by vessel tortuosity.Paradise catheter was never inflated nor was any sonication provided the left renal artery.Although the returned devices had tears which appeared to be due to tortuous anatomy, this is highly unlikely related to the adverse event.As per physician, the anticoagulation dose was inadequate.Post procedural renal angiogram noted a clot partially occluding the left renal artery.The clot was treated with unilateral thrombectomy using penumbra pump (cat6) which restored the blood flow.Following the thrombectomy procedure, the patient was transferred to the icu.A contrast-enhanced ct scan was performed noted areas of infarction in the left kidney.Patient condition improved and discharged under stable condition 3 days later.Suboptimal anticoagulation dose along with forced insertion of paradise catheters against challenging anatomy, atherosclerosis, and vascular injury from multiple devices including the accessory devices, likely contributed to the event.

• 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: 23812610
• Report Number: 3010024164-2025-00004
• Device Sequence Number: 15774450
• Product Code: QYI
• UDI-Device Identifier: 00810008950005
• UDI-Public: 00810008950005
• 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): 12/15/2025

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: M4308, M4347, M4733
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (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: 014X190 ABBOTT BALANCED MIDDLEWEIGHT GUIDE WIRE; 7FR.X11CM SHEATH; TWO CORDIS RDC (RENAL DOUBLE CURVE) GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female