RUSCH IPN050146Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704308019), received between Apr 24, 2023 and May 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deflation 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 16, 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.

• MalfunctionMay 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "WHEN REMOVING THE PROBE {THE USER] DEFLATED THE CATHETER CUFF, REMOVED 10 ML OF WATER THAT WAS INSIDE THE CUFF AND AT THE TIME OF REMOVAL, AT THE TIME THE PROBE CAME OUT THE PROBE HAD A KNOT AT THE TIP. EVEN THOUGH THERE WAS NO RESISTANCE AT THE TIME OF REMOVAL, THE PATIENT PRESENTED A MEDIUM AMOUNT OF BLEEDING FROM THE URETHRA." THE PATIENT'S CURRENT CONDITION IS UNKNOWN. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 19354253 ↗
• MalfunctionApr 24, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A "PATIENT WITH AN INDWELLING BLADDER CATHETER CATHETERIZED 3 WEEKS BEFORE. PATIENT CAME BACK TO THE HOSPITAL, THE CATHETER SELF-EXPELLED. THE BALLOON WAS FULLY DEFLATED. I INSERTED A SIMILAR DEVICE, SAME LOT#. I INFLATED THE BALLOON WITH 10 CC. THE PATIENT CAME BACK ON THE SAME DAY AT 5:00 PM, THE CATHETER HAD FALLEN OUT AGAIN, THE BALLOON WAS COMPLETELY CRACKED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16795026 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A "PATIENT WITH AN INDWELLING BLADDER CATHETER CATHETERIZED 3 WEEKS BEFORE. PATIENT CAME BACK TO THE HOSPITAL, THE CATHETER SELF-EXPELLED. THE BALLOON WAS FULLY DEFLATED. I INSERTED A SIMILAR DEVICE, SAME LOT#. I INFLATED THE BALLOON WITH 10 CC. THE PATIENT CAME BACK ON THE SAME DAY AT 5:00 PM, THE CATHETER HAD FALLEN OUT AGAIN, THE BALLOON WAS COMPLETELY CRACKED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16794987 ↗
• MalfunctionApr 24, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A "PATIENT WITH AN INDWELLING BLADDER TUBE THAT I PROBED 3 WEEKS AGO, RETURNS TODAY BECAUSE HE LOST IT, THE BALLOON IS COMPLETELY DEFLATED, I CHANGE THE RUSCH CH 16 SILICONE BRAND PROBE (THE SAME AS THE PATIENT HAD) BY INFLATING THE BALLOON TO 10 CC. THE PATIENT COMES BACK AT 5 P.M., THE PROBE HAS FALLEN AGAIN, THE BALLOON IS COMPLETELY CRACKED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16794883 ↗