Bard® Urethral Catheter 120612Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741029950), received between Mar 8, 2022 and Apr 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (3 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.

• MalfunctionApr 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE END-USER INSERTED INTERMITTENT LATEX CATHETER INTO URETHRA TO BLADDER AND PROCEEDED TO EMPTY BLADDER INTO THE CONTAINER. DURING THE PROCESS, THE PATIENT NOTICED THAT THEIR THIGH WAS GETTING WET. UPON EXAMINATION A SMALL HOLE WAS NOTED NEXT TO THE KNOB (BUMP) ON THE HUB. WHEN THE BLADDER WAS EMPTY, THE CATHETER TIP SYRINGE WAS PLACED INTO HUB AND THUMB WAS USED TO COVER THE HOLD AND BCG INSTALLED. THE PATIENT DENIED GETTING WET AFTER THE FIRST INCIDENT. NO SAMPLE WAS KEPT; HOWEVER, PICTURES OF INCIDENT ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829669 ↗
• MalfunctionMar 8, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING AND UNABLE TO USE EVEN AFTER IRRIGATION. PER FOLLOW UP ON (B)(6) 2022, IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING EVEN AFTER IRRIGATION AND STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694306 ↗
• MalfunctionMar 8, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING AND UNABLE TO USE EVEN AFTER IRRIGATION. PER FOLLOW UP ON (B)(6) 2022, IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING EVEN AFTER IRRIGATION AND STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694275 ↗
• MalfunctionMar 8, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING AND UNABLE TO USE EVEN AFTER IRRIGATION. THE AFFECTED LOTS WERE (LOT# NGFT5816, LOT# NGFU4453, LOT# NGFR1186). PER FOLLOW UP ON 14-FEB-2022, IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE CLOGGING EVEN AFTER IRRIGATION AND STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694061 ↗