Navina™ Rectal Catheter Set Regular 68940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387024745), received between Mar 18, 2026 and Apr 29, 2026 — classified as 2 malfunctions.

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.

• MalfunctionApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT USING THE NAVINA CLASSIC TRANSANAL IRRIGATION SYSTEM WITH NAVINA REGULAR RECTAL BALLOON CATHETERS REPORTED REPEATED BALLOON RUPTURES DURING USE. THE PATIENT INDICATED THAT DURING A SINGLE DAY OF USE, APPROXIMATELY SIX CATHETERS EXPERIENCED BALLOON RUPTURE WHILE IN SITU. OVER THE SUBSEQUENT SIX DAYS, THE PATIENT REQUIRED THE USE OF APPROXIMATELY TWO CATHETERS PER DAY DUE TO SIMILAR FAILURES. THE REPORTED BALLOON RUPTURES OCCURRED EITHER IMMEDIATELY DURING BALLOON INFLATION OR WITHIN 1-2 MINUTES FOLLOWING INFLATION DURING THE IRRIGATION PHASE. THE PATIENT STATED THAT THE DEVICE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE, WITH NO PERCEIVED RESISTANCE DURING INSERTION AND CONFIRMATION THAT THE BALLOON WAS FULLY POSITIONED WITHIN THE RECTUM PRIOR TO INFLATION. THE PATIENT REPORTED PERFORMING APPROXIMATELY 5-6 PUMP STROKES FOR BALLOON INFLATION, FOLLOWED BY IRRIGATION FOR APPROXIMATELY 7-8 MINUTES. THE PATIENT REPORTED ASSOCIATED SYMPTOMS INCLUDING MILD RECTAL BLEEDING (DESCRIBED AS A FEW DROPS OBSERVED IN THE TOILET) OCCURRING IMMEDIATELY FOLLOWING AT LEAST ONE BALLOON RUPTURE, AS WELL AS RECTAL DISCOMFORT AND PAIN PERSISTING OVER A PERIOD OF APPROXIMATELY 4-5 DAYS. THE PA

  Patient problems: Pain

  MAUDE report 25027438 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  YOUNG FEMALE PATIENT, WHO HAS A HISTORY OF SPINA BIFIDA, WAS USING THE MANUAL NAVINA CLASSIC SYSTEM WITH RECTAL BALLOON CATHETER AT HOME UNDER THE CARE OF HER MOTHER (CAREGIVER). ACCORDING TO THE CAREGIVER, THE RECTAL BALLOON RUPTURED TWICE ON THE SAME DAY WHILE INFLATING WITH APPROXIMATELY 3-4 PUMPS OF AIR. THE CAREGIVER REPORTS THAT THE RECTAL CATHETER WAS LUBRICATED APPROPRIATELY AND INSERTED TO THE CORRECT DEPTH. SHE STATED THAT SIMILAR BALLOON FAILURES HAVE OCCURRED IN THE PAST. THE CAREGIVER ALSO REPORTED A SEPARATE EVENT INVOLVING THE PATIENT'S FOLEY CATHETER. AFTER TRANSFERRING FROM THE TOILET BACK TO THE BED, THE CAREGIVER FOUND THAT THE FOLEY CATHETER HAD BEEN UNINTENTIONALLY EXPELLED WITH THE BALLOON STILL INTACT. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT, WHERE THE FOLEY WAS REINSERTED. THE CAREGIVER QUESTIONED WHETHER THIS EXPULSION COULD BE RELATED TO THE USE OF THE NAVINA SYSTEM. IT WAS EXPLAINED TO HER THAT THIS IS UNLIKELY, AS REMOVAL OF AN INTACT FOLEY BALLOON TYPICALLY REQUIRES CONSIDERABLE TRACTION AND MAY HAVE OCCURRED DURING PATIENT TRANSFER. THE PATIENT HAS EXPERIENCED SOME VAGINAL DISCOMFORT AND BACK PAIN. BACK PAIN IS COMMON FOR HER DUE TO UNDERLYIN

  Patient problems: Pain

  MAUDE report 24625993 ↗