Bardia® Foley Catheter Silicone Coated 123620ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741095214), received between Jun 5, 2018 and Jul 10, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25784138 ↗
• MalfunctionMay 23, 2026Complete Blockage

  IT WAS REPORTED THAT THE UROLOGY DEPARTMENT AS CATHETERIZATION, DRAINAGE AND FLUSHING. ON (B)(6) 2026, THE PATIENT'S INLET FAILED DURING BLADDER IRRIGATION AFTER ELECTRODESICCATION OF A BLADDER TUMOR, AND SUBSEQUENT EXAMINATION REVEALED COMPLETE OCCLUSION OF THE INLET LUMEN OF THE BARD TRIPLE LUMEN CATHETER 20CH FR. CAUSED THE PATIENT TO HAVE A RED, SWOLLEN, AND PAINFUL URETHRAL OPENING; INCREASED THE NUMBER OF CATHETER CHANGES. MEASURES TAKEN 12MAY2026. TREATMENT TAKEN IMMEDIATE REPLACEMENT WITH A NEW CATHETER FOLLOWED BY SMOOTH BLADDER IRRIGATION. TIME TO IMPROVEMENT OF ADVERSE EVENT: 12MAY2026.

  Patient problems: Pain; Skin Discoloration; Swelling/ Edema

  MAUDE report 25266198 ↗
• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT FLEXIBLE URETEROSCOPY. A URINARY FOLEY CATHETER WAS LEFT IN PLACE POSTOPERATIVELY FOR DRAINAGE. WHILE CHECKING THE PATENCY OF THE CATHETER, THE PHYSICIAN NOTICED THAT IT HAD DISLODGED. UPON EXAMINATION, IT WAS FOUND THAT THE BALLOON HAD SPONTANEOUSLY RUPTURED, AND THE CATHETER WAS IMMEDIATELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677632 ↗
• MalfunctionNov 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON THE FIRST DAY AFTER TRANSURETHRAL RESECTION OF THE PROSTATE, THE PATIENT HAD A THREE-WAY INDWELLING FOLEY CATHETER PROPERLY SECURED. AT 15:00, THE CATHETER FELL OUT ON ITS OWN, ALTHOUGH THE ADHESIVE FIXATOR WAS STILL IN PLACE. THE DOCTOR WAS IMMEDIATELY INFORMED, AND TEMPORARY OBSERVATION WAS CONDUCTED WITHOUT RE-INSERTING THE CATHETER. AT 16:47, THE PATIENT URINATED SMOOTHLY, AND THE URINE WAS LIGHT RED IN COLOR.

  Patient problems: Hematuria

  MAUDE report 23518950 ↗
• MalfunctionOct 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, THE FOLEY CATHETER HAD SLIPPED, TESTING SHOWED THAT THE BALLOON WAS LEAKED WATER ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335260 ↗
• MalfunctionAug 15, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT WOULD LIKE TO KNOW THE SIZE OF THE EYELETS ON FOLEYS 0166SI20 & 123620A. ALSO STATES PATIENT KNOWS THEY ARE DIFFERENT SIZES BY COMPARING THEM SIDE BY SIDE, THE 123620A SEEMED TO CLOG MORE WITH SEDIMENT AND WANT TO KNOW WHAT DOES THE SILVER ALLOY COATING MEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813670 ↗
• MalfunctionJan 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT HAD A DISTENDED ABDOMEN AND COULD NOT URINATE ON OWN. THE DOCTOR ORDERED AN INDWELLING URINARY CATHETER. THE NURSE SELECTED A 20CH/FR URINARY FOLEY CATHETER, WHICH WAS CHECKED BEFORE THE OPERATION. THE CATHETER TIP WAS LUBRICATED WITH AN IODINE COTTON BALL AND ASEPTIC OPERATION WAS STRICTLY PERFORMED. THE INSERTION PROCESS WAS SMOOTH, WITH A DEPTH OF 18 CM. AFTER THE INJECTION, 15 ML OF STERILE WATER WAS INJECTED WITH A 30 ML SYRINGE, AND THE URINE WAS DISCHARGED SMOOTHLY. ON DECEMBER 18, THE NURSE MADE ROUNDS AND FOUND THAT THE CATHETERIZATION WAS NOT SMOOTH. AFTER ASPIRATING THE BALLOON, ONLY A SMALL AMOUNT OF LIQUID WAS FOUND. 20 ML OF STERILE WATER FOR INJECTION WAS RE-INJECTED AND USED NORMALLY. THE NIGHT SHIFT NURSE FOUND THAT THE FOLEY CATHETER HAD SLIPPED AND THE BALLOON WAS DEFLATED. AFTER THE CATHETER WAS REPLACED IMMEDIATELY, URINATION WAS NORMAL. CATHETERIZATION WAS PERFORMED TWICE IN A ROW, WHICH INCREASED THE PATIENT'S PAIN AND THE COST OF THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 21167455 ↗
• MalfunctionNov 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621682 ↗
• MalfunctionOct 9, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD LONG-TERM INDWELLING CATHETERIZATION. ON 30AUGUST2024, THE CATHETER WAS REPLACED. A 20CH/FR CATHETER WAS SELECTED. IODINE SOLUTION WAS SELECTED FOR LUBRICATION. ASEPTIC OPERATION WAS STRICTLY FOLLOWED. THE INSERTION PROCESS WAS SMOOTH. THE DEPTH WAS 6CM. 20ML OF NORMAL SALINE WAS INJECTED. THE DRAINAGE WAS SMOOTH. ON 5SEPTEMBER2024, THE CATHETER WAS FOUND TO BE DETACHED. INSPECTION FOUND THAT THERE WAS STILL LIQUID IN THE BALLOON. THE CATHETER WAS REPLACED, AND DRAINAGE WAS SMOOTH. CATHETERIZATION INCREASED THE PATIENT'S PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 20406634 ↗
• MalfunctionMay 22, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAD 3 INSTANCES OVER THE PAST COUPLE OF WEEKS WITH CATHETERS THAT SEEM TO HAVE A FAULTY BALLOON. 2 OF THESE PATIENTS HAVE HAD TO GO TO THE ER TO HAVE THE CATHETER REMOVED AND THE PHYSICIANS IN THE ER WERE ALSO UNABLE TO DEFLATE THE BALLOON. ONE OF THEM HAD TO HAVE A PROCEDURE TO REMOVE IT AND THE OTHER THEY WERE ABLE TO CUT THE CATHETER AND EVENTUALLY THE BALLOON DEFLATED. THE ER PHYSICIAN STATED THAT THEY WERE PERPLEXED AS TO WHY THE BALLOON WOULD NOT DEFLATE. THE 3RD PATIENT WAS GOING TO THE ER TODAY AS HIS WAS STILL DRAINING AND THEY DID NOT WANT TO GO LAST NIGHT. 2 OF THESE CATHETERS ARE THE SAME BRAND AND ITEM NUMBER ¿ BARD 18FR 802318. THEY WERE UNABLE TO FIND A LOT NUMBER IN MCKESSON TO SEE IF THEY WERE THE SAME. THE 3RD PATIENT ALSO HAD A BARD 20 FRENCH WITH 30CC BALLOON 802320. THEY WERE CONCERNED THAT THERE MAY BE A FAULTY LOT NUMBER. THEY DID NOT WANT PATIENTS HAVING TO GO TO THE ER AND HAVE PROCEDURES THAT ARE UNNECESSARY WHEN THEY ARE ALREADY EXPERIENCING HEALTH ISSUES. SAME BRAND AND ITEM NUMBER ¿ BARD 18FR 802318. THEY WERE UNABLE TO FIND A LOT NUMBER IN MCKESSON TO SEE IF THEY WERE THE SAME. THE 3RD PATIENT ALSO HAD A BARD 20 FRENCH WITH 30

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371034 ↗
• MalfunctionDec 29, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WAS DEFECTIVE. BALLOON WOULD NOT INFLATE. PATIENT COULD NOT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418722 ↗
• MalfunctionJul 5, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT UPON INJECTING STERILE WATER, THE WATER LEAKED FROM THE FOLEY BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256253 ↗
• MalfunctionMar 1, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON WATER WAS UNABLE TO ESCAPE. THE PATIENT STATUS/ INTERVENTION WAS CUT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459705 ↗
• MalfunctionDec 29, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PATIENT HAD A FOLEY CATHETER IN PLACE FOR OVER 15 YEARS. IT WAS ALSO STATED THAT OVER THE LAST SIX MONTHS, THEY HAVE OBSERVED THAT THERE WAS BLOOD PRESENT DURING CATHETER CHANGES ABOUT ONCE PER MONTH AND IT WAS MORE PAINFUL THAN USUAL AND THERE WAS SOMETIMES A BLEB AT THE END OF THE INFLATION TUBING AND THE NURSE WAS HAVING DIFFICULTY INFLATING THE BALLOON. ALSO STATED THAT THEY HAVE NOTICED LEAKAGE AROUND THE FOLEY. ALSO, WHEN THE NURSE WAS INSERTING THE CATHETER, THEY INSERT IT JUST UNTIL URINE WAS FLOWING, THEN MIGHT ADVANCE IT SLIGHTLY, BUT PULLS THE CATHETER BACK BEFORE INFLATING THE 30CC BALLOON. REPRESENTATIVE EXPLAINED THAT THE ISSUE MIGHT BE RELATED TO IMPROPER INSERTION TECHNIQUES. ADVISED THAT ON INSERTION THE CLINICIAN SHOULD ENSURE THAT THE FOLEY CATHETER BALLOON WAS POSITIONED WELL WITHIN THE PATIENT¿S BLADDER. THEN SLOWLY, WITH A GENTLY, WITH A GENTLE, CONSTANT FORCE, INFLATE THE FOLEY CATHETER BALLOON WITH THE VOLUME PRESCRIBED ON THE PACKAGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067753 ↗
• MalfunctionDec 29, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT PATIENT HAD A FOLEY CATHETER IN PLACE FOR OVER 15 YEARS. STATED THAT OVER THE LAST SIX MONTHS, THEY HAVE OBSERVED THAT THERE WAS BLOOD PRESENT DURING CATHETER CHANGES ABOUT ONCE PER MONTH AND IT WAS MORE PAINFUL THAN USUAL AND THERE WAS SOMETIMES A BLEB AT THE END OF THE INFLATION TUBING AND THE NURSE WAS HAVING DIFFICULTY INFLATING THE BALLOON. STATED THAT THEY HAVE NOTICED LEAKAGE AROUND THE FOLEY. ALSO, WHEN THE NURSE WAS INSERTING THE CATHETER, THEY INSERT IT JUST UNTIL URINE WAS FLOWING, THEN MIGHT ADVANCE IT SLIGHTLY, BUT PULLS THE CATHETER BACK BEFORE INFLATING THE 30CC BALLOON. REPRESENTATIVE EXPLAINED THAT THE ISSUE MIGHT BE RELATED TO IMPROPER INSERTION TECHNIQUES. ADVISED THAT ON INSERTION THE CLINICIAN SHOULD ENSURE THAT THE FOLEY CATHETER BALLOON WAS POSITIONED WELL WITHIN THE PATIENT¿S BLADDER. THEN SLOWLY, WITH A GENTLE, CONSTANT FORCE, INFLATE THE FOLEY CATHETER BALLOON WITH THE VOLUME PRESCRIBED ON THE PACKAGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067743 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT HAD A FOLEY CATHETER IN PLACE FOR OVER 15 YEARS. STATED THAT OVER THE LAST SIX MONTHS, THEY HAVE OBSERVED THAT THERE WAS BLOOD PRESENT DURING CATHETER CHANGES ABOUT ONCE PER MONTH AND IT WAS MORE PAINFUL THAN USUAL AND THERE WAS SOMETIMES A BLEB AT THE END OF THE INFLATION TUBING AND THE NURSE WAS HAVING DIFFICULTY INFLATING THE BALLOON. IT WAS ALSO STATED THAT THEY HAVE NOTICED LEAKAGE AROUND THE FOLEY. ALSO, WHEN THE NURSE WAS INSERTING THE CATHETER, THEY INSERT IT JUST UNTIL URINE WAS FLOWING, THEN MIGHT ADVANCE IT SLIGHTLY, BUT PULLS THE CATHETER BACK BEFORE INFLATING THE 30CC BALLOON. REPRESENTATIVE EXPLAINED THAT THE ISSUE MIGHT BE RELATED TO IMPROPER INSERTION TECHNIQUES. ADVISED THAT ON INSERTION THE CLINICIAN SHOULD ENSURE THAT THE FOLEY CATHETER BALLOON WAS POSITIONED WELL WITHIN THE PATIENT¿S BLADDER. THEN SLOWLY, WITH A GENTLY, WITH A GENTLE, CONSTANT FORCE, INFLATE THE FOLEY CATHETER BALLOON WITH THE VOLUME PRESCRIBED ON THE PACKAGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067672 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT LAST FOLEY CATHETER WAS LEAKING BAD. IT ONLY HAPPENED WITH THE LAST ONE THEY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627248 ↗
• MalfunctionSep 29, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW WHAT TYPE OF COATING WAS ON A FOLEY CATHETER. STATED THAT THE DARK BROWN CATHETERS WERE DRY ROTTED, CAUSING THE CATHETERS COLOR TO COME OFF INSIDE OF THE PATIENT SO THAT THE CATHETER WAS BROWN WHEN INSERTED INTO THE PATIENT BUT WAS YELLOW WHEN REMOVED. AS PER FOLLOW UP VIA MAIL ON 21SEP2022, CUSTOMER PROVIDED THE PCN# (B)(4). ALSO STATED THAT WHEN CATHETER WAS REMOVED FROM PATIENT THE PART OF THE CATHETER THAT WAS INSIDE, WAS A MUCH LIGHTER, YELLOW COLOR, VS THE LIGHT BROWN OF THE ORIGINAL AND REST OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505981 ↗
• MalfunctionJul 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED AND PATIENT HAD TO REPLACE TWO BEFORE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042024 ↗
• MalfunctionJul 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING FROM THE INSERTION SITE AND THE CATHETER HAD TO BE CHANGED TWO DIFFERENT TIMES BEFORE THE CORRECT CHANGE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040636 ↗
• InjuryFeb 2, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT DID NOT LIKE THE FOLEY CATHETERS, AND THEY WERE NOT WORKING FOR THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW UP VIA PHONE 12JAN2022, IT WAS STATED THAT THE PATIENT USED A CLEAR , HARD, STIFF CATHETER THAT DID CAUSED HER IRRITATION AND SPASMS. THE PATIENT DID NOT HAVE THE NAME OR LOT NUMBER AVAILABLE. THE PATIENT WENT TO THE DOCTOR AND WAS GIVEN PRESCRIPTION MEDICINE FOR THE SPASMS AND THE PATIENT SWITCHED BACK TO THE CATHETERS THAT THE PATIENT USUALLY USED. THE PATIENT DID NOT KNOW THE NAME OF THE MEDICINE THE PATIENT WAS PRESCRIBED. THE PATIENT NORMAL CATHETERS WERE REDDISH BROWN IN COLOR. THE PATIENT HAD NO FURTHER IRRITATION ISSUES SINCE SWITCHING BACK TO THE PATIENT USUAL CATHETER BUT THE PATIENT WAS EXPERIENCING LEAKAGE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Skin Inflammation/ Irritation

  MAUDE report 13433216 ↗
• InjuryFeb 2, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PATIENT DID NOT LIKE THE FOLEY CATHETERS, AND THEY WERE NOT WORKING FOR THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 12JAN2022, IT WAS STATED THAT THE PATIENT USED A CLEAR, HARD, STIFF CATHETER WHICH CAUSED IRRITATION AND SPASMS. THE PATIENT WENT TO THE DOCTOR AND WAS GIVEN A PRESCRIPTION MEDICINE FOR THE SPASMS AND THE PATIENT SWITCHED BACK TO THE CATHETERS THAT THE PATIENT USUALLY USES. THE PATIENT DID NOT KNOW THE NAME OF THE PRESCRIBED MEDICINE. THE PATIENT¿S NORMAL CATHETER WAS REDDISH BROWN IN COLOR. THE PATIENT HAD NO FURTHER IRRITATION ISSUES SINCE SWITCHING BACK TO THE USUAL CATHETER, BUT THE PATIENT WAS EXPERIENCING LEAKAGE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Skin Inflammation/ Irritation

  MAUDE report 13429008 ↗
• MalfunctionJun 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAS LEAKED AND DOES NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999875 ↗
• MalfunctionFeb 9, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON DID NOT DRAIN COMPLETELY AND DIFFICULT TO WITHDRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11305339 ↗
• MalfunctionDec 29, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT CATHETERS WERE CLOGGING AFTER TWO WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11087758 ↗