RUSCH IPN050171Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704334964), received between Apr 14, 2022 and May 11, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Burst Container or Vessel; Burst Container or Vessel

  AS PER ACCOUNT, THIS TYPE AND SIZE OF FOLEY CATHETER WAS INSERTED IN ONE OF OUR PATIENTS TODAY AND THE BALLOON BUSTED. THE NURSE REPORTED USING ABOUT 25CC OF WATER WHEN SHE HEARD A POP, NOT SURE IF THIS IS AN ISOLATED INCIDENT. THE BRAND IS NOT OUR USUAL BRAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14356129 ↗
• MalfunctionApr 18, 2022Burst Container or Vessel; Burst Container or Vessel

  PATIENT REPORTING A 3RD FAILURE OF HIS RUSCH 100% 18FR 30CC FOLEY. HE SAID IT IS THE SAME LOT AS THE 2 YOU ARE ALREADY AWARE OF. THIS ONE IS KEY-MR. (B)(6). TOLD ME THE HISTORY AND THE 2 PREVIOUS BALLOONS BURST AFTER INSERTION AND HAD NOT BEEN PRE-TESTED. THE CLINICIAN THAT CAME TO INSERT THE LATEST CATHETER THAT FAILED PRE-TESTED THE BALLOON BEFORE INSERTION; IT BURST IN HIS HAND BEFORE 20ML WATER HAD BEEN INTRODUCED. THIS ELIMINATES THE POSSIBILITY OF SOMETHING WITHIN MR. (B)(6) BLADDER DAMAGING THE BALLOON (IE: STONES, OR DIFFUSION DUE TO OSMOSIS, ETC.). I JUST WANTED TO MAKE YOU AWARE SO THAT YOU COULD INCLUDE THE ADDITIONAL FAILURE AND NEW INFORMATION ON YOUR REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136307 ↗
• MalfunctionApr 14, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER CALLED STATING THAT HE HAD TWO CATHETER BALLOONS TO BURST WITHIN THE LAST WEEK. ONE OCCURRED AFTER TWO DAYS AND THE OTHER OCCURRED WITHIN HOURS OF INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115891 ↗
• MalfunctionApr 14, 2022Burst Container or Vessel; Burst Container or Vessel

  CUSTOMER CALLED STATING THAT HE HAD TWO CATHETER BALLOONS TO BURST WITHIN THE LAST WEEK. ONE OCCURRED AFTER TWO DAYS AND THE OTHER OCCURRED WITHIN HOURS OF INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115847 ↗