CARDINAL HEALTH SENHDBUNO1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439517255), received between Aug 15, 2025 and Nov 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE, FOLEY CATHETER BALLOON BURST DURING INFLATION AT 7.5 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23608561 ↗
• MalfunctionNov 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THEY HAD RECEIVED ANOTHER COMPLAINT FROM THEIR DEPARTMENT REGARDING A CATHETER IN A 12CH LUBRISIL FOLEY TRAY AND THERE HAD BEEN A FURTHER ISSUE WITH A FOLEY CATHETER TODAY DURING THE ELECTIVE CAESAREAN SECTION IT FELL OUT POST LOT NGKU2949 FIRST ISSUE IN A WHILE SO THEY DID NOT WANT TO REMOVE THE WHOLE STOCK AS IT COULD BE A ONE OFF. PER NOTIFICATION FROM INVESTIGATOR ON 05JAN2026 IT WAS REPORTED THAT THE FAILURE BALLOON CUFFING WAS FOUND WAS FOUND DURING SAMPLE EVALUATION ON 09DEC2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490104 ↗
• MalfunctionAug 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, FOLEY CATHETER FELL OUT OF PATIENT WHEN TRANSFERRING THE PATIENT AND CATHETER HAD A HOLE IN THE BALLOON ON INSPECTION (LOT #NGKN1639). PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 12AUG2025, STATED THAT NO HARM TO THE PATIENT WAS REPORTED. MIDWIFE WAS PRESENT, THE CATHETER WAS INSERTED AND WORKING WELL IT WAS ON TRANSFERRING THE PATIENT POST-SURGERY THAT THE CATHETER FELL OUT. IT WAS ASSUMED THE WATER THAT WAS INSERTED INTO THE BALLOON THE WATER HAS DRAINED OUT, WHEN LOOKING AT THE CATHETER AFTERWARDS THERE APPEARED TO BE A HOLE IN THE BALLOON. ONLY THE WATER PROVIDED WAS USED IN THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED ON 12AUG2025, STATED THAT THE SAME ISSUE WITH THE CATHETER APPEARS TO BE THE LATEX FREE ONE LAST NIGHT (LOT #NGKQ1102). PER NOTIFICATION FROM INVESTIGATOR ON 05JAN2026, IT WAS REPORTED THAT THE FOR CATHETER 1 BALLOON WAS NOTED TO INFLATED ASYMMETRICALLY AND WATER DEFLATION ISSUE, FOR CATHETER 2 ASYMMETRICAL BALLOON AND WATER DEFLATION ISSUE, FOR CATHETER 3 ASYMMETRICAL BALLOON AND BALLOON MUSHROOMING ISSUE, FOR CATHETER 4 BALLOON WAS NOTED TO INFLATED ASYMMETRICALLY, FOR CATHETER 5 ASYMMETRICAL BALLOON AND BALLOON MUSHROOMING ISSUE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815354 ↗