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

Model Number	PRDS-067-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event: renal artery dissection.Event description: 40 yr old male patient underwent renal denervation procedure on (b)(6) 2026.After sonication of the left main renal artery, a dissection was noted in one of the branches of left main renal artery.It was confirmed that the dissection was caused due to inadvertent use of an oversized balloon (7 mm balloon in a 4.8 mm vessel) because of inaccurate measurement of the vessel diameter from pre-procedural ct scan.To manage the dissection, an onyx balloon (medtronic) was inflated at the dissection site for 3 mins to facilitate the reapposition of the dissection flap and to support spontaneous sealing of the dissection.The event resolved, patient was stable post procedure and discharged on (b)(6) 2025 after 24 hours of observation.

• 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: 24754221
• Report Number: 3010024164-2026-00002
• Device Sequence Number: 21009427
• Product Code: QYI
• UDI-Device Identifier: 00810008950036
• UDI-Public: 00810008950036
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/31/2026

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 Model Number: PRDS-067-02
• Device Lot Number: M4901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male