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 07392532198434), received between May 9, 2018 and Oct 2, 2023 — 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.

• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT, HAD SURGERY AND IRRADIATION FOR COLORECTAL CANCER A FEW YEARS AGO. THE PATIENT HAS CURRENTLY ANAL PROLAPSE AND HAS ISSUES WITH FREQUENCY AND INCOMPLETE BOWEL EMPTYING, FOR WHICH SHE WAS PRESCRIBED TRANSANAL IRRIGATION. THE PATIENT GOT A PRODUCT INSTRUCTION ON (B)(6) FROM A NURSE TRAINER. A FOLLOW-UP TELEPHONE CALL BETWEEN THE NURSE AND THE PATIENT FOLLOWED ON (B)(6). THE PATIENT SAID THAT SHE WAS BLEEDING. THE NURSE ADVISED HER TO HAVE THIS URGENTLY CLARIFIED BY A DOCTOR. THE INCIDENT REPORTED WAS ON (B)(6), THE NURSE DOES NOT KNOW WHETHER THE PATIENT FOLLOWED THE ADVICE AND SAW A DOCTOR OR CONTINUED THE THERAPY BETWEEN ON (B)(6) SINCE SHE COULD NOT REACH THE PATIENT BY PHONE DURING THIS WEEK. THE PATIENT WAS ALONE WHEN USING THE DEVICE AND THE RECTAL CATHETER BALLOON DID NOT BURST INSIDE THE RECTUM WHICH NORMALLY IS A CAUSE OF BOWEL PERFORATION. ACCORDING TO THE REPORTED COMPLAINT, THE PATIENT INJURED HER BOWEL SO BADLY THAT EMERGENCY SURGERY WAS REQUIRED. A LARGE PIECE OF THE INTESTINE WAS REMOVED. THE PATIENT NOW HAS AN ARTIFICIAL OUTLET. SHE WAS IN AN ARTIFICIAL COMA (SEDATED), AND SHE HAS BEEN BROUGHT OUT OF THE COMA. BECAUSE INTESTINAL CONTENTS LEAKED INTO T

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 17849685 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT ACCIDENTALLY LOST HER BALANCE DURING INSERTION OF THE RECTAL CATHETER (PROVIDED IN THE NAVINA CLASSIC SYSTEM). THIS LED TO BOWEL PERFORATION. THE PATIENT IMMEDIATELY SOUGHT MEDICAL CARE AND A PERMANENT FISTULA WAS PLACED. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

  Patient problems: Bowel Perforation

  MAUDE report 7497585 ↗