Navina™ Classic System Regular 69005 (REF 6900540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387025803), received between Mar 3, 2025 and May 18, 2026 — classified as 2 injuries.

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.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  A 28-YEAR-OLD PATIENT EXPERIENCED A BOWEL PERFORATION FOLLOWING TRANSANAL IRRIGATION WITH A NAVINA CLASSIC SYSTEM AND RECTAL BALLOON CATHETER ON (B)(6) 2026. THE PROCEDURE WAS PERFORMED AT HOME BY A NEWLY TRAINED NURSE DURING HER FIRST INDEPENDENT USE. DURING THE PROCEDURE, THE CATHETER WAS INSERTED AND THE BALLOON INFLATED (2 PUMPS). THE CATHETER WAS EXPELLED WITH THE BALLOON STILL INFLATED. AFTER DEFLATION, THE CATHETER WAS REINSERTED AND REINFLATED; HOWEVER, IT WAS AGAIN EXPELLED WITH THE BALLOON INFLATED. A THIRD INSERTION ATTEMPT WAS MADE, DURING WHICH RESISTANCE WAS ENCOUNTERED AND MINOR BLEEDING WAS OBSERVED. IRRIGATION WAS SUBSEQUENTLY PERFORMED IN TWO INTERRUPTED ATTEMPTS WITH APPROXIMATELY 450 ML OF WATER INSTILLED. THE PATIENT DEVELOPED SYMPTOMS IMMEDIATELY AFTER THE PROCEDURE AND WAS TRANSPORTED TO THE EMERGENCY ROOM THE SAME DAY. THE PATIENT UNDERWENT SURGICAL REPAIR OF A BOWEL PERFORATION ON (B)(6) 2026, FOLLOWED BY A SECOND SURGERY FOR COLOSTOMY ON (B)(6) 2026. THE PATIENT IS CURRENTLY HOSPITALIZED AND STABLE.

  Patient problems: Internal Organ Perforation

  MAUDE report 25197527 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN ADVERSE EVENT OCCURRED OUTSIDE THE UNITED STATES. A 53-YEAR-OLD MALE PATIENT, WITH A PREVIOUS HISTORY OF NEUROGENIC BOWEL DYSFUNCTION DUE TO SPINAL CORD INJURY, WAS PRESCRIBED A NAVINA CLASSIC SYSTEM, A TRANSANAL IRRIGATION SYSTEM WITH A RECTAL BALLOON CATHETER. THE PATIENT AND HIS CAREGIVER RECEIVED HANDS-ON TRAINING, AND THE PATIENT STARTED THE PROCEDURE BY THE CAREGIVER'S HELP. ON (B)(6), DURING THE IRRIGATION PROCEDURE, THE PATIENT COMPLAINED ABOUT PAIN, AND BLEEDING WAS DISCOVERED DURING IRRIGATION. THE CAREGIVER SLIGHTLY REMOVED THE BALLOON CATHETER. IT WAS CONFIRMED BY THE CAREGIVER THAT THE BALLOON CATHETER DID NOT BURST. A DAY LATER, THE PATIENT WAS BROUGHT TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH BOWEL PERFORATION, WHICH REQUIRED IMMEDIATE EMERGENCY SURGERY. AS OF THE DATE OF THIS INCIDENT, THE PATIENT IS RECOVERING WELL AFTER THE STOMA SURGERY.

  Patient problems: Internal Organ Perforation

  MAUDE report 21502060 ↗