RestoreX 117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860001453805), received between May 15, 2026 and May 15, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Use of Incorrect Control/Treatment Settings

  CUSTOMER REPORTED THAT USE OF THE RESTOREX DEVICE RESULTED IN A TEAR IN THE CORPUS SPONGIOSUM, WORSENING ERECTILE FUNCTION, URINARY INCONTINENCE, AND ONGOING PAIN AND INFLAMMATION. THE CUSTOMER STATED THE DEVICE WAS USED ACCORDING TO INSTRUCTIONS, INCLUDING USE AT MAXIMUM TENSION SETTINGS OVER AN EXTENDED PERIOD. PATHRIGHT REQUESTED SUPPORTING MEDICAL RECORDS AND IMAGES TO EVALUATE THE ALLEGATIONS; HOWEVER, NO DOCUMENTATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND INTERNAL REVIEW, THE REPORTED INJURIES WERE NOT VERIFIED, AND NO CAUSAL RELATIONSHIP TO THE DEVICE COULD BE ESTABLISHED.

  Patient problems: Pain; Tissue Irritation; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 25191794 ↗
• MalfunctionMay 15, 2026Use of Device Problem

  PATIENT REPORTED USING THE DEVICE APPROXIMATELY 5 HOURS PER DAY, EXCEEDING THE INSTRUCTIONS FOR USE WHICH STATE NOT TO USE THE DEVICE FOR MORE THAN 1 HOUR PER DAY OR MORE THAN 30 MINUTES AT A TIME AND TO SEPARATE SESSIONS BY AT LEAST 30 MINUTES. THE PATIENT ALSO REPORTED TIGHTENING THE CLAMP BEYOND NORMAL USE AND APPLYING MAXIMUM TENSION, SOMETIMES MANUALLY INCREASING FORCE. THE PATIENT REPORTED DECREASED PENILE SENSITIVITY AND WEAKER ERECTIONS. ON (B)(6) 2023 THE PATIENT WAS EVALUATED BY A UROLOGIST AND UNDERWENT A PENILE ULTRASOUND ON (B)(6) 2023. THE PATIENT REPORTED THAT THE ULTRASOUND SHOWED NUMERICAL FINDINGS SUGGESTIVE OF A POSSIBLE VENOUS LEAK. NO SURGICAL INTERVENTION OR HOSPITALIZATION WAS REPORTED. THE PATIENT WAS ADVISED TO DISCONTINUE USE. FOLLOW UP COMMUNICATION MONTHS LATER INDICATED THAT THE PATIENT REPORTED HIS CONDITION HAD RETURNED TO NORMAL. NO DEVICE MALFUNCTION WAS REPORTED.

  Patient problems: Erectile Dysfunction; Hypoesthesia

  MAUDE report 25191793 ↗