Navina™ Consumable set regular 69003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07392532198403), received between Jan 22, 2019 and Sep 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Adverse Event Without Identified Device or Use Problem

  Caregiver reported that the balloon of a Navina Classic Regular rectal catheter ruptured multiple times during use. The patient uses the Navina system daily with approximately 500-600 mL of water and inflates the balloon using 1-2 pump strokes. The caregiver reported that the balloon rupture occurred during irrigation and that both the patient and caregiver could hear and feel the balloon rupture. No pain, bleeding, or other injury was reported. The patient has been using the Navina system since 2024. The caregiver inserts the catheter, while the patient controls balloon inflation and water volume.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911077 ↗
• MalfunctionFeb 27, 2020Product Quality Problem; Product Quality Problem

  BALLOON BURST INSIDE PATIENT. NO INFORMATION ABOUT ANY MEDICAL COMPLICATION RECEIVED. INCIDENT OCCURED IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9762557 ↗
• MalfunctionJan 22, 2019Product Quality Problem; Product Quality Problem

  A PATIENT WITH PREVIOUS MEDICAL HISTORY OF A BOWEL PERFORATION INCIDENT, WHEN USING ANOTHER MANUFACTURER'S PRODUCT FOR TRANS ANAL IRRIGATION, REPORTED PAIN AND SUSPECTED BALLOON BURST AND DAMAGE TO INTESTINE WHEN USING THE RECTAL CATHETER REGULAR (SUPPLIED WITHIN THE CONSUMABLE SET REGULAR). THE PATIENT SOUGHT HOSPITAL CARE THE DAY AFTER. THE HEALTH CARE PROVIDER DID NOT CONSIDER IT LIKELY CAUSED BY THE BALLOON BURST. THE PATIENT HAD A CONTRAST SCAN, BUT NO PHYSICAL DAMAGE WAS SEEN. THE REPORTER STATED THE GENERAL DIAGNOSIS FROM THE HOSPITAL AND GPS ALONG WITH THE BOWEL NURSE, IS THAT THE INNER WALL OF THE INTESTINE HAD BEEN HURT. IT WAS DESCRIBED BY REPORTER AS "NOT A FULL PERFORATION AND HARD TO SEE ON THE SCANS, BUT STILL A TRAUMA". THE PATIENT INFORMED SHE HAS BEEN TO THE DOCTOR'S REGULARLY SINCE THE EVENT, AND EXPERIENCE CONTINUED ABDOMINAL PAIN AND DISCOMFORT, AND HAD NOT HEALED AT TIME OF RAISING COMPLAINT. TREATED WITH ANALGESIC MEDICATION FOR PAIN AND INFLAMMATION. IS NOT USING THE IRRIGATION SYSTEM SINCE THE EVENT OCCURRED.

  Patient problems: Abdominal Pain

  MAUDE report 8266889 ↗