Rutner G14920Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002149205), received between Dec 18, 2017 and May 3, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2018Detachment Of Device Component

  IT WAS REPORTED THAT SOMETIME AFTER ESTABLISHING A BLADDER FISTULA WITH THE RUTNER SUPRAPUBIC BALLOON CATHETER SET, THE BALLOON CAME OFF. THE FISTULA WAS REESTABLISHED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS ADDITIONAL PROCEDURE. NO PIECES OF THE COMPLAINT DEVICE WERE LEFT IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7484001 ↗
• InjuryMay 3, 2018Deflation Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER PLACING THE RUTNER SUPRAPUBIC BALLOON CATHETER, THE PHYSICIAN FOUND THAT THE BALLOON HAD DEFLATED. THE DEVICE WAS REMOVED AND REPLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7483839 ↗
• InjuryMay 2, 2018Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RUTNER SUPRAPUBIC BALLOON CATHETER HAD FALLEN OUT WITHIN A DAY AFTER PLACEMENT, AND THAT THE BALLOON WAS FOUND TO BE BROKEN. A NEW DEVICE WAS PLACED, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE. NO PART OF THE COMPLAINT DEVICE REMAINED IN THE PATIENT'S BODY.

  Patient problems: No Code Available

  MAUDE report 7481388 ↗
• InjuryMay 2, 2018Device Operates Differently Than Expected; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RUTNER SUPRAPUBIC BALLOON CATHETER FELL OUT OF THE PATIENT ONE DAY AFTER BEING PLACED. THE BALLOON WAS REINFLATED TO PLACE THE DEVICE AGAIN, BUT IT STOPPED DRAINING TWO DAYS LATER. A NEW CATHETER WAS PLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7481251 ↗
• MalfunctionDec 18, 2017Break; Break

  THE USER FACILITY REPORTED OF A RUTNER SUPRAPUBIC BALLOON CATHETER SET IMPLANTED AND THEN EXPLANTED DUE TO A BROKEN CONNECTION PIECE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125518 ↗