Navina™ Classic Control Unit 69013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387028330), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  A 63 YEAR OLD FEMALE PATIENT WITH A HISTORY OF CHRONIC BOWEL DYSFUNCTION, KNOWN RECTAL INTUSSUSCEPTION, AND SEVERE CONSTIPATION WAS USING THE NAVINA CLASSIC BOWEL IRRIGATION SYSTEM WITH A REGULAR RECTAL BALLOON CATHETER FOR BOWEL MANAGEMENT. THE PATIENT HAD BEEN PRESCRIBED NAVINA IN (B)(6) 2025 AND STARTED USING THE SYSTEM IN (B)(6) 2026, REPORTING POSITIVE THERAPEUTIC BENEFIT AND REDUCED EMERGENCY DEPARTMENT VISITS. ON (B)(6) 2026, AT APPROXIMATELY 11:00 AM, THE PATIENT PERFORMED HER MOST RECENT BOWEL IRRIGATION USING THE NAVINA CLASSIC SYSTEM. THE IRRIGATION CONSISTED OF SPLIT ADMINISTRATIONS APPROXIMATELY 15 MINUTES APART, WITH AN ESTIMATED IRRIGATION VOLUME OF 100-200 ML DURING THE FIRST IRRIGATION AND 300-400 ML DURING THE SECOND IRRIGATION. BROWN EFFLUENT WAS EXPELLED FOLLOWING IRRIGATION, WHICH IS CONSISTENT WITH STOOL EVACUATION. THE PATIENT REPORTED INTERMITTENT ABDOMINAL DISCOMFORT DURING IRRIGATION, WHICH SHE STATED IS TYPICAL FOR HER AND OCCURS BOTH WITH AND WITHOUT USE OF THE DEVICE. APPROXIMATELY TWO HOURS AFTER COMPLETION OF IRRIGATION, THE PATIENT DEVELOPED INCREASING LOWER ABDOMINAL PAIN. NO RECTAL BLEEDING WAS REPORTED. THE PAIN WORSENED OVERNIGHT. ON THE MORNING

  Patient problems: Abdominal Pain

  MAUDE report 24949835 ↗