Bard® Silastic® Foley Catheter 33624Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741020100), received between Apr 6, 2021 and May 21, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 23, 2026Class IIOpen, Classified

   Due to stain present on the surface of affected foley catheters.

   Z-2226-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Complete Blockage

  IT WAS REPORTED THAT CUSTOMER STATED FOLEY CATHETERS CLOGGED REALLY FAST AND LEAKED EVERYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250175 ↗
• MalfunctionDec 31, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY RECEIVED THE SILASTIC 24FR CATHETERS IN SEPTEMBER BUT DID NOT OPEN THEM UNTIL NOVEMBER. PATIENT'S CATHETER WAS CHANGED MID NOVEMBER AND USUALLY LASTS 10 TO12 WEEKS. THE CATHETER KEPT PLUGGING, WHICH WAS UNUSUAL. FIRST ONE, USED APPROXIMATELY TWO WEEKS, WOULD NOT RUN APPROXIMATELY 6 TIMES PLUGGED. THAT WAS UNUSUAL. EACH TIME THEY WERE ABLE TO GET URINE TO FLOW AGAIN BY DEFLATING THE BALLOON. IT WAS BECOMING MORE FREQUENT. THEY ASKED HOME CARE NURSES TO CHANGE THE FOLEY CATHETER. THEY DID ON DECEMBER 1ST. THE NEW CATHETER RAN WELL FOR A FEW DAYS BUT STARTED TO STOP WORKING AND GOT PROGRESSIVELY WORSE, UNTIL IT WOULD STOP WORKING 3 AND 4 TIMES A DAY. AT THAT POINT THEY WENT TO EMERGENCY IN ARIZONA. THAT WAS ON DECEMBER 10. THEY DID NOT CARRY SILASTIC FOLEY'S AND REPLACED THERE WITH A TEMPERATURE CATHETER. PROBLEMS SOLVED. RUNNING WELL, NO BLOCKAGES. PATIENT HAD USUALLY HIS SILASTIC FOLEY IN PLACE FOR UP TO 12 WEEKS WITH NO BLOCKAGES. THAT WHOLE PROBLEM WAS VERY UNUSUAL FOR HIM. THE FIRST CATHETER IN NOVEMBER WAS THE START OF THAT LOT NUMBER. PATIENT HAD PROBLEMS WITH BOTH CATHETERS OF THAT LOT NUMBER AND NO PROBLEMS WITH THE EMERGENCY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936718 ↗
• InjuryDec 29, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY RECEIVED THE SILASTIC 24FR CATHETERS IN SEPTEMBER BUT DID NOT OPEN THEM UNTIL NOVEMBER. PATIENT'S CATHETER WAS CHANGED MID NOVEMBER AND USUALLY LASTS 10 TO 12 WEEKS. THE CATHETER KEPT PLUGGING, WHICH WAS UNUSUAL. FIRST ONE, USED APPROXIMATELY TWO WEEKS, WOULD NOT RUN APPROXIMATELY 6 TIMES PLUGGED. THAT WAS UNUSUAL. EACH TIME THEY WERE ABLE TO GET URINE TO FLOW AGAIN BY DEFLATING THE BALLOON. IT WAS BECOMING MORE FREQUENT. THEY ASKED HOME CARE NURSES TO CHANGE THE FOLEY CATHETER. THEY DID ON DECEMBER 1ST. THE NEW CATHETER RAN WELL FOR A FEW DAYS BUT STARTED TO STOP WORKING AND GOT PROGRESSIVELY WORSE, UNTIL IT WOULD STOP WORKING 3 AND 4 TIMES A DAY. AT THAT POINT THEY WENT TO EMERGENCY IN (B)(6). THAT WAS ON DECEMBER 10. THEY DID NOT CARRY SILASTIC FOLEY'S AND REPLACED THERE WITH A TEMPERATURE CATHETER. PROBLEMS SOLVED. RUNNING WELL, NO BLOCKAGES. PATIENT HAD USUALLY HIS SILASTIC FOLEY IN PLACE FOR UP TO 12 WEEKS WITH NO BLOCKAGES. THAT WHOLE PROBLEM WAS VERY UNUSUAL FOR HIM. THE FIRST CATHETER IN NOVEMBER WAS THE START OF THAT LOT NUMBER. PATIENT HAD PROBLEMS WITH BOTH CATHETERS OF THAT LOT NUMBER AND NO PROBLEMS WITH THE EMERGENCY

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23917255 ↗
• MalfunctionNov 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON WORKS FOR A DAY OR TWO AND THEN OBSTRUCTS THE URINARY TRACT. WHEN CHANGING THE CATHETER, THE BALLOON DID NOT DEFLATE, THEY HAVE TO FORCE IT BECAUSE THE TUBE FLATTENS. DURING A CATHETER CHANGE, THEY HAD TO CUT IT TO DEFLATE THE BALLOON BEFORE REMOVING IT. CUSTOMER CALLED CONCERNING A HOME PATIENT. CUSTOMER WOULD LIKE TO KNOW IF A CREDIT NOTE WILL BE GIVEN OR A BOX OF PRODUCTS. PER FOLLOW UP INFORMATION RECEIVED ON 10MAR2026, IT WAS REPORTED UNFORTUNATELY, THE USER PASSED AWAY IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657354 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, IT WAS UNABLE TO DEFLATE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467211 ↗
• MalfunctionNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER STATED THE SILASTIC FOLEY CATHETER WAS INFLATED AND UNABLE TO USE BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467055 ↗
• MalfunctionOct 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE SMALL AND ARE NOT GETTING ENOUGH SUCTION. THEY GET FULL SO EASY. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335259 ↗
• MalfunctionOct 16, 2025Collapse; Collapse

  IT WAS REPORTED THAT THE FOLEY CATHETER COLLAPSED INSIDE AND WOULD NOT LET URINE DRAIN. DRAINAGE TUBING CRIMP. URINE WAS BACKED UP. LOT NGKQ3862, THIS HAS BEEN ON GOING. CUSTOMER HAS EXISTING COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309901 ↗
• MalfunctionOct 9, 2025Collapse; Collapse

  IT WAS REPORTED THAT THE CUSTOMER STATES THAT THEY WERE USING THE FOLEY CATHETER 5CC AND THE CATHETER WAS COLLAPSING, NOT ALLOWING URINE TO FLOW THROUGH. THEY HAD 2 OCCURRENCES OF THIS. THEY HAD THE 2 CATHETERS TO RETURN IF NEEDED. CUSTOMER WOULD LIKE REPLACEMENTS. WITH THE CATHETERS NOT WORKING, THEY GOT BLADDER SPASMS. THEY HAD ANOTHER COMPLAINT OPENED BECAUSE OF THIS ISSUE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 23257397 ↗
• MalfunctionOct 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT UNABLE TO DEFLATE THE BALLOON ONCE THE FOLEY CATHETER WAS NEEDED TO BE REPLACED. NO FLUID WAS ABLE TO BE PULLED INTO THE SYRINGE TO DEFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222982 ↗
• MalfunctionSep 10, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AS PER CLIENT, SINCE THE FIRST FOLEY CATHETER, IT WAS BALLOON HAS BEEN SLOWLY DEFLATING UNTIL IT BLOCKED THE CATHETER. THEY DEFLATE WHAT REMAINED IN THE BALLOON TO 7CC, AND AFTER TWO DAYS, IT REMAINED AT 4CC. THEN THE CATHETER UNBLOCKED, THEY PUT BACK 7CC, AND EVERYTHING WORKED AS BEFORE. UNTIL IT DEFLATED AGAIN, AND THE CATHETER WAS BLOCKED ONCE MORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020180 ↗
• MalfunctionSep 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOONS ON THE CUSTOMERS FOLEY CATHETERS ARE HARD TO INFLATE AND DEFLATE. CUSTOMER DOES NOT WANT TO USE THEM AS THEY WERE HESITANT BECAUSE THEY ARE WORKING AS DESIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017188 ↗
• MalfunctionSep 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOONS ON THE CUSTOMERS FOLEY CATHETERS ARE HARD TO INFLATE AND DEFLATE. CUSTOMER DOES NOT WANT TO USE THEM AS THEY WERE HESITANT BECAUSE THEY ARE WORKING AS DESIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017019 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKS AND BLOCKS THE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411765 ↗
• MalfunctionJul 7, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKS AND BLOCKS THE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411717 ↗
• MalfunctionMay 30, 2025Collapse; Collapse

  IT WAS REPORTED THAT THE FOLEY CATHETER COLLAPSED INSIDE AND WOULD NOT LET URINE DRAIN. DRAINAGE TUBING CRIMP. URINE WAS BACKED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113604 ↗
• MalfunctionMar 25, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM # 5733624 BUT RECEIVED ITEM # (B)(6) INSIDE THE PRODUCT BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687832 ↗
• MalfunctionAug 28, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON OF FOLEY CATHETER WAS FILLED WITH SALINE, AND IT COLLAPSED LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084707 ↗
• MalfunctionJan 23, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RESTRICTED FLOW AND THE BALLOON COLLAPSE ON ITSELF. PER FOLLOW UP VIA PHONE ON 18-JAN-2023, IT WAS REPORTED THAT THE CUSTOMER STILL HAD THE CATHETER AND WOULD SEND IN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224122 ↗
• MalfunctionJan 23, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD RESTRICTED FLOW AND THE BALLOON COLLAPSE ON ITSELF. PER FOLLOW UP VIA PHONE ON18-JAN-2023, IT WAS REPORTED THAT THE CUSTOMER STILL HAD THE CATHETER AND WOULD SEND IN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224000 ↗
• MalfunctionApr 28, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LAST COUPLE OF TIMES THE PATIENT HAD CHANGED THE SILASTIC FOLEY CATHETER. STATED THAT IT WAS COMPLETELY PLUGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240550 ↗
• MalfunctionJan 13, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOONS WERE IN THE WRONG PLACE AND THE HOLES WERE IN DIFFERENT PLACES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13254240 ↗
• MalfunctionJan 13, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOONS WERE IN THE WRONG PLACE AND THE HOLES WERE IN DIFFERENT PLACES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13253413 ↗
• MalfunctionApr 13, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT 4 CATHETERS OUT OF THE BOX WERE DEFECTIVE. PATIENT DESCRIBED THAT THE BALLOON BLOWS UP BUT ALSO INDICATED THAT THE PART WHERE THE USER ADD WATER TO FILL THE BALLOON WAS BLOWING UP AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662176 ↗
• MalfunctionApr 6, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PATIENT INDICATED THE URINARY CATHETER WAS THICKER THAN THE PREVIOUS ONES THEY HAD USED. ALSO STATED THAT PATIENT REGULARLY USE 24FR MEASUREMENT. THIS URINARY PROBE CAUSED DISCOMFORT WHEN INSERTING THE PROBE INTO THE URINARY MEATUS.

  Patient problems: Discomfort

  MAUDE report 11620063 ↗