RUSCH IPN050125Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04026704307968), received between Mar 16, 2018 and Dec 10, 2024 — classified as 8 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "RUSCH PEDIATRIC FOLEY 3170003060 6FR, WAS BEING USED FOR A VCUG PROCEDURE WHEN THE TECH INJECTED THE CONTRAST MEDIA THE CATHETER HAD A HOLE ABOUT 2 INCHES FROM THE OUTER CONNECTION, IT CAUSED DIFFICULTY INJECTING THE CONTRAST, THE RADIOLOGIST DECLINED TO CHANGE IT AND PRESUMABLY OBTAINED THE IMAGES NEEDED. THE CATHETER WAS INADVERTENTLY THROWN OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892419 ↗
• MalfunctionApr 24, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE, THE CATHETER BALLOON WOULD NOT DEFLATE. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19176856 ↗
• MalfunctionApr 24, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE, THE CATHETER BALLOON WOULD NOT DEFLATE. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19176825 ↗
• MalfunctionNov 28, 2022Break; Break

  REPORTED ISSUE: THIS IS THE SECOND DEFECTIVE CATHETER FOUND ON THE UNIT OF THE SAME SIZE. THIS ONE WAS FOUND DAMAGED BEFORE USE. THE DAMAGE IS THE GUIDE WIRE HAS POKED THROUGH THE SILICONE MATERIAL OF THE CATHETER MAKING IT DEFECTIVE. THIS WOULD HAVE CAUSED TRAUMA TO THE PATIENT IF USED IN THIS CONDITION. THE OTHER BROKE OFF AFTER INSERTION INTO A PATIENT AT THE VERTEX WHERE THE CATHETER AND BALLOON CHAMBER CONVERGE. THIS CAUSED DELAY IN TREATMENT AND THE TRAUMA OF REMOVING THE BROKEN CATHETER AND REPLACING A NEW ONE INTO THE PEDIATRIC PATIENT. WE DID NOT KEEP THE BROKEN ONE BECAUSE IT WAS EXPOSED TO BODILY SECRETIONS. IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870132 ↗
• MalfunctionSep 1, 2022Off-Label Use; Material Perforation; Off-Label Use; Material Perforation

  (B)(4). PEDIATRIC PATIENT WITH FOREIGN OBJECT IN NOSE. PROVIDER USED RUSCH PEDIATRIC FOLEY CATHETER TO REMOVE FOREIGN OBJECT FROM NOSE. UPON REMOVING THE CATHETER FROM THE NOSE, THE PHYSICIAN REPORTED THE STYLET HAD PUNCTURED THE CATHETER AND WAS STICKING OUT OF THE SIDE OF THE CATHETER. NO INJURY TO THE PATIENT WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337375 ↗
• MalfunctionMay 11, 2022Break; Break

  THE PROBE BREAKS WHEN INSTALLED ON THE PATIENT. SOMETIMES AFTER A FEW HOURS AND SOMETIMES AFTER A FEW DAYS. THEY BROKE ON SLEEPING, SEDATED LITTLE BABIES WHO DID NOT MOVE. THE PATIENTS WHO HAD THE CATHETERS IN PLACE WERE ALL SMALL, INTUBATED PATIENTS UNDER 8KG. THE CATHETERS WERE ALL SIZE 6 FRENCH. THE LAST PATIENT WAS A CARDIAC SURGERY PATIENT WHO WAS INTUBATED, SEDATED AND CRITICAL. LESS THAN 3KG. IN ALL CASES THE PARTS WERE ALL REMOVED WITHOUT OBVIOUS COMPLICATIONS. NEW CATHETERS WERE INSTALLED AS WAS NECESSARY TO THE PATIENT'S CONDITION WITH EXTRA SURVEILLANCE BY THE NURSE. I CANNOT RECALL IF THERE WERE ANY URINARY INFECTION PROPHYLACTIC ANTIBIOTICS GIVEN TO THE PATIENTS ON RELATED TO THE BREAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14358414 ↗
• MalfunctionMay 27, 2021No Flow; No Flow

  NURSE REPORTS THAT THE CATHETER WAS PLACED BUT THERE WAS NO URINE OUTPUT DURING PROCEDURE. THE CATHETER WAS REMOVED AND REPLACED AND URINE RETURNED. THE ORIGINAL CATHETER WAS INSPECTED AND FLUSHED. THIS WAS DONE TO SEE IF SOMETHING MAY HAVE BLOCKED FLOW (IE: STONES, ETC). THE NURSE NOTED THAT THERE DID NOT SEEM TO BE ANY EYELETS AT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895039 ↗
• MalfunctionMar 16, 2018Hole In Material; Defective Device

  FOLEY NOTED TO BE DEFECTIVE. HOLE IN TUBING (INDICATED BETWEEN RED MARKS ON CATHETER). DID NOT NEGATIVELY IMPACT THE PATIENT. A NEW FOLEY WAS USED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7344628 ↗