Bard® Lubricath® Foley Catheter 366714Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741077838), received between May 24, 2021 and Feb 13, 2024 — classified as 1 injury, 3 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.

• MalfunctionFeb 13, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS SITTING ALONG THE INSIDE ASPECT OF THIGH (HAD COME OUT OF BLADDER). ON CLOSER INSPECTION, THERE WAS AN INCISION LIKE SEPARATION IN THE BALLOON OF THE CATHETER THAT CAUSED THE BALLOON TO COLLAPSE AND THE CATHETER TO COME OUT OF THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694300 ↗
• MalfunctionJan 23, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS SITTING ALONG THE INSIDE ASPECT OF THIGH (HAD COME OUT OF BLADDER). ON CLOSER INSPECTION, THERE WAS AN INCISION LIKE SEPARATION IN THE BALLOON OF THE CATHETER THAT CAUSED THE BALLOON TO COLLAPSE AND THE CATHETER TO COME OUT OF THE BLADDER. NEW CATHETER HAD TO BE REINSERTED INTO BLADDER. THEY DIDN'T REPORT HAVING ANY PAIN OR DISCOMFORT AT TIME OF INSPECTION OR NEW CATHETER INSERTION. NEW CATHETER WAS DRAINING CLEAR AMBER URINE.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562196 ↗
• InjuryJul 21, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER WAS CLIMBING THROUGH A FENCE ON SUNDAY EVENING AND HEARD A POP NOISE. SHORTLY AFTER, THE CUSTOMER'S FOLEY CATHETER HAD FALLEN OUT. THE CUSTOMER EXAMINED SAME AND FOUND THE BALLOON ON THE END OF THE CATHETER HAD RUPTURED. THE CUSTOMER THEN PHONED THE HOME CARE OFFICE THE NEXT MORNING AND REPORTED SAME TO THE HOME CARE NURSE. THE CUSTOMER CAME TO THE OFFICE AND HAD SAME REINSERTED. NO APPARENT HARM REACHED THE PATIENT. THE IMPACT OF THE INCIDENT WAS PATIENT WAS UNABLE TO VOID. THE PATIENT REQUIRED UNEXPECTED OR PROLONGED CARE.

  Patient problems: Urinary Retention

  MAUDE report 17370638 ↗
• MalfunctionMay 24, 2021Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE 14 FR 30 CC FOLEY CATHETER BALLOON DID NOT DRAIN PROPERLY FOR 30 TO 45 MINUTES WHEN THE PATIENT CAME TO THE EMERGENCY ACUTE ONSET OF SEVERE PAIN IN THE SUPRAPUBIC AREA BILATERALLY. IT WAS NOTICED THAT THE CATHETER BALLOON WAS RUPTURED AFTER 8 DAYS OF PLACEMENT. AND ALSO STATED THAT THE PATIENT HAD IMMEDIATE PAIN RELIEF AND WAS ABLE TO URINATE AND EMPTY THE BLADDER.

  Patient problems: Pain

  MAUDE report 11872059 ↗