Navina™ Smart System Regular 69009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387027364), received between Dec 12, 2024 and Dec 13, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WITH A SPINAL CORD INJURY AT THE C5 LEVEL AND NEUROGENIC BOWEL, FOLLOWED BY CHRONIC CONSTIPATION, HAS BEEN PRESCRIBED THE NAVINA CLASSIC RECTAL IRRIGATION SYSTEM WITH A BALLOON CATHETER. THE PATIENT HAS BEEN USING THE NAVINA SYSTEM SINCE 2022, WITH A WATER IRRIGATION VOLUME OF 1000 ML. RECENTLY, THE PATIENT NOTICED SEVERAL BALLOON BURSTS IN THE RECTUM, ALL INVOLVING CATHETERS FROM THE SAME LOT NUMBER. ALTHOUGH THERE WERE NO MEDICAL COMPLICATIONS FROM THE BALLOON BURSTS, THE PATIENT EXPERIENCED A PRESSURE IN THE RECTUM WHEN THE BALLOON BURST.

  Patient problems: Abdominal Pain

  MAUDE report 20922725 ↗
• InjuryDec 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A FOREIGN INCIDENT OCCURRED OUTSIDE UNITED STATES. A 65-YEAR-OLD MALE PATIENT, WHO UNDERWENT AN INTESTINAL ANASTOMOSIS OPERATION MORE THAN TEN YEARS AGO, WAS PRESCRIBED A NAVINA SMART TRANSANAL IRRIGATION (TAI) SYSTEM WITH A RECTAL BALLOON CATHETER IN 2022. ACCORDING TO THE COMPLAINT, THE PATIENT HAD BEEN USING TRANSANAL IRRIGATION SINCE HIS INTESTINAL ANASTOMOSIS OPERATION TEN YEARS AGO, BUT IT IS UNKNOWN WHICH SYSTEM (BRAND) WAS USED BEFORE HE WAS PRESCRIBED THE NAVINA SMART TAI SYSTEM. ACCORDING TO THE INFORMATION COMMUNICATED TO THE MANUFACTURER, THE PATIENT RECEIVED AT-HOME TRAINING FROM THE THIRD-PARTY MEDICAL SUPPLY REPRESENTATIVE AND BECAME FAMILIAR WITH THE DEVICE INSTRUCTIONS FOR USE. THE PATIENT USED THE DEVICE WITHOUT ANY PROBLEM, BUT ON (B)(6), HE WAS ADMITTED TO THE HOSPITAL DUE TO A BOWEL PERFORATION. THE PERFORATION RESULTED IN AN EMERGENCY OPERATION WITH FECAL PERITONITIS, NECESSITATING RESECTION AND OSTOMY FORMATION, FOLLOWED BY THE DAILY USE OF OSTOMY AIDS AFTER THE OPERATION. AT THE TIME OF THE INCIDENT, THE RECTAL BALLOON CATHETER WAS SET TO SETTING 5, WHICH IS THE MAXIMUM BALLOON SIZE (VOLUME), WITH A WATER FLOW OF 500 ML.

  Patient problems: Bowel Perforation

  MAUDE report 20910758 ↗