Bard® Silastic® Foley Catheter 33418Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741019999), received between Dec 21, 2017 and Apr 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY THE CUSTOMER THAT TWO CATHETERS RECEIVED FROM THE ALBERTA AIDS TO DAILY LIVING PHARMACY FAILED TO DRAIN AS INTENDED. AS A RESULT, THE PATIENT EXPERIENCED BLADDER SPASMS AND URINE BYPASSING, WHICH NECESSITATED CATHETER REPLACEMENT. THE FIRST CATHETER INSERTION OCCURRED ON MONDAY MORNING, AND A SECOND CATHETER WAS INSERTED MONDAY EVENING DUE TO CONTINUED FAILURE TO DRAIN. A THIRD CATHETER INSERTION OCCURRED ON TUESDAY AFTERNOON USING HOME CARE STOCK, AT WHICH TIME MORE THAN 1,600 MILLILITERS OF URINE DRAINED WITHIN TWO HOURS. THE PRODUCT INVOLVED WAS A SILASTIC FOLEY CATHETER, 18 FRENCH, WITH A 30-CC RIBBED BALLOON MADE OF SILASTIC MATERIAL.

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

  MAUDE report 24861204 ↗
• MalfunctionApr 8, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY CUSTOMER THAT TWO CATHETERS RECEIVED FROM ALBERTA AIDS TO DAILY LIVING PHARMACY FAILED TO DRAIN AS INTENDED, WHICH RESULTED IN BLADDER SPASMS, URINE BYPASSING, AND CATHETER REPLACEMENT FOR THE PATIENT. THE FIRST CATHETER INSERTION OCCURRED ON MONDAY MORNING AND THE SECOND CATHETER INSERTION OCCURRED ON MONDAY EVENING DUE TO CONTINUED FAILURE TO DRAIN. A THIRD CATHETER INSERTION OCCURRED ON TUESDAY AFTERNOON USING HOME CARE STOCK, AND MORE THAN ONE THOUSAND SIX HUNDRED MILLILITERS OF URINE DRAINED WITHIN TWO HOURS. THE PRODUCT INVOLVED WAS SILASTIC FOLEY CATHETER EIGHTEEN FRENCH WITH THIRTY CUBIC CENTIMETER RIBBED BALLOON MADE OF SILASTIC MATERIAL.

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

  MAUDE report 24819089 ↗
• MalfunctionAug 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNABLE TO INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849778 ↗
• MalfunctionJan 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE COMING OUT WITH DEFLATED BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265074 ↗
• MalfunctionMar 14, 2024Disconnection; Component Misassembled; Disconnection; Component Misassembled

  IT WAS REPORTED THAT THE CONNECTOR OF THE FOLEY CATHETER CAME RECESSED WHERE THE SYRINGE SHOULD BE PLACED TO INFLATE THE BALLOON. THE DEVICE WAS NOT USED ON THE PATIENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 12MAR2024, THE CUSTOMER CONFIRMED THAT THEY WERE NOT STICKING TOGETHER. WHEN THEY WERE ABOUT TO USE AND OPENED THE PACKAGE THEY NOTICED THAT THE CONNECTOR WAS SUBMERGED WHERE THE SYRINGE WAS PLACED TO INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903844 ↗
• MalfunctionAug 23, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ONE OF THESE FOLEY CATHETER TRAY FELL OUT AND ANOTHER THE TOP BROKE. PER FOLLOW UP VIA PHONE ON 08AUG2023, IT WAS REPORTED THAT THE CUSTOMER PULLED A CATHETER OUT OF THE BOX AND THE TOP WAS BROKEN AND LIQUID SPILLED OUT. CUSTOMER STATED THAT THEY HAD BEEN USING THE PRODUCT FOR YEARS AND NEVER HAD THIS ISSUE. CUSTOMER ALSO INQUIRED ABOUT HAVING THE DEFECTIVE CATHETERS BEING REPLACED. CUSTOMER WAS ADVISED TO CONTACT LIBERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606681 ↗
• MalfunctionJan 9, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE SILASTIC FOLEY CATHETERS WERE COMING APART. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW UP VIA PHONE ON 22DEC2022, IT WAS REPORTED THAT THE CUSTOMER RECEIVED NEW DRAIN BAGS WHICH WAS ALSO UNGLUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120438 ↗
• InjuryApr 28, 2020Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT CAME INTO THE HOSPITAL FOR A ROUTINE CATHETER CHANGE ON HIS SUPRAPUBIC LATEX FOLEY. DURING THE REMOVAL PROCESS THE FOLEY WAS UNABLE TO BE DEFLATED. THE RN WAS UNABLE TO DEFLATE THE 33CC BALLOON AND RECEIVED ASSISTANCE FROM THE PA WHO WAS UNSUCCESSFUL AS WELL. AT THIS TIME THE PA AND RN WERE INSTRUCTED TO CUT INCHES ABOVE THE Y AND THE FLUID STILL DID NOT RELEASE. PATIENT WAS TRANSFERRED TO THE ER, AND WAS PUNCTURED WITH A SPINAL NEEDLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10006312 ↗
• MalfunctionSep 16, 2019Deflation Problem; Material Puncture/Hole; Deflation Problem

  IT WAS REPORTED THAT THE USER NOTICED A HOLE ON THE BALLOON WHILE CHECKING THE PERMEABILITY OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9070374 ↗
• MalfunctionFeb 28, 2018Defective Device

  IT WAS REPORTED THAT THE CATHETER BLOWS LIKE A BALLOON AND IS DEFECTIVE. FIVE SAMPLES WILL BE RETURNED AND IT IS UNKNOWN IF THEY HAVE ALL BEEN USED.

  Patient problems: No Information

  MAUDE report 7302944 ↗
• MalfunctionDec 21, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER STOPPED DRAINING ON THE SECOND WEEK OF USE. THE USER BELIEVED THAT IT WAS BLOCKED BY SOMETHING. IT WAS STATED BY THE USER THAT THE CATHETER WOULD NORMALLY LAST BETWEEN FOUR TO SIX WEEKS. THERE WAS NO KNOWN CHANGE IN ENVIRONMENT OR DRUGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138082 ↗