Rutner G15261Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002152618), received between May 2, 2018 and Oct 8, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2018Inflation Problem; Inflation Problem

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942447 ↗
• InjuryMay 3, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RUTNER SUPRAPUBIC BALLOON CATHETER DECANNULATED ONE DAY AFTER PLACEMENT. ANOTHER DEVICE WAS PLACED, AND THERE WERE NO FURTHER INJURIES ASIDE FROM THE ADDITIONAL PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7483551 ↗
• InjuryMay 3, 2018Deflation Problem; Device Slipped

  IT WAS REPORTED THAT TWO DAYS AFTER PLACEMENT, THE RUTNER SUPRAPUBIC BALLOON CATHETER FELL OUT OF THE PATIENT, AND ITS BALLOON SEEMED DEFLATED. ANOTHER DEVICE WAS PLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THE REPLACEMENT PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7483457 ↗
• InjuryMay 2, 2018Migration or Expulsion of Device; No Flow

  THE COMPLAINANT REPORTED THAT THE RUTNER SUPRAPUBIC BALLOON CATHETER WAS PLACED PERCUTANEOUSLY IN THE URINARY BLADDER FOR A CYSTOSTOMY. APPROXIMATELY 7 DAYS LATER, IT WAS NOTICED THAT URINE WAS NOT DRAINING. ECHOGRAPHIC EXAMINATION CONFIRMED THAT THE CATHETER MIGRATED, AND THE TIP OF THE CATHETER WAS NOT PLACED INSIDE THE URINARY BLADDER. THE BALLOON WAS NOTED TO BE DAMAGED WHEN THE PHYSICIAN REMOVED THE DEVICE. ANOTHER RUTNER SUPRAPUBIC BALLOON CATHETER (UNKNOWN LOT NUMBER) WAS PLACED INSTEAD. ASIDE FROM THE ADDITIONAL PROCEDURE THAT WAS REQUIRED TO REPLACE THE DEVICE, THERE WAS NO ADDITIONAL PATIENT HARM REPORTED FOR THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 7479556 ↗