Bardex® I.C. Foley Catheter 0166SI24Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741016882), received between Nov 29, 2018 and Jan 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE STAFF HAVE NOTICED ON 2 SEPARATE OCCASIONS THE BALLOON ON THE 24 FRENCH FOLEYS HAVE BEEN LEAKING FROM THE BALLOON. STAFF RESTOCKED THESE AND WAS ABLE TO PULL A LOT NUMBER FROM THEM (NGKU3016).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036572 ↗
• MalfunctionJul 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY WOULD NOT DEFLATE AND USED 1 INSERTION TRAY WHEN THE DEFECTIVE ITEM WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531134 ↗
• MalfunctionNov 8, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE INSTRUCTIONS FOR USE (IFU) DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION AS THEY DID NOT AGREE WITH THE STATEMENT SAYING THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCT(S) PROVIDED SUFFICIENT INFORMATION ABOUT THE PRODUCT(S) AND THEIR MEDICAL APPLICATION(S) IN RELATION TO BARDEX I.C. 2 WAY FOLEY CATHETER (STRIP PACK) (FRENCH SIZE 24) AND INFORMED THAT IN THEIR OPINION THE IFU DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT PREVIOUSLY MENTIONED AND ITS MEDICAL APPLICATION BECAUSE OF INADEQUATE OR INSUFFICIENT TRAINING, BARDEX I.C. 2 WAY COUNCIL TIP FOLEY CATHETER (STRIP PACK) NO FRENCH SIZE SPECIFIED AND INFORMED THAT IN THEIR OPINION THE IFU DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT PREVIOUSLY MENTIONED AND ITS MEDICAL APPLICATION BECAUSE OF MISSING INFORMATION ALSO STATED THAT THEY WAS NOT ABLE TO SUCCESSFULLY ACHIEVE HEMOSTASIS WHILE USING THE LARGE 30CC BALLOON BECAUSE OF NEOPLASTIC BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753906 ↗
• MalfunctionAug 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A HOLE IN THE TUBING JUST ABOVE THE OUTFLOW CHIP. THE PROCEDURE WAS CORONARY ARTERY BYPASS GRAFTING AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294297 ↗
• MalfunctionApr 6, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE CLOGGING WHICH MADE THE PATIENT TO CHANGE THEM QUICKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624836 ↗
• MalfunctionOct 20, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON WITH 20CC WATER WAS NOT MAKING A ROUND BALLOON, THE PATIENT IS USING THE CATHETER AS A FEEDING TUBE PER THE DOCTOR¿S INSTRUCTIONS,PER TROUBLESHOOTING THE MSS RESPONSE THE METHOD OF INFLATING THE BALLOON. FOLLOW UP 1 VIA PHONE ON 25SEP2020, THE CUSTOMER NOTED THAT THE BALLOON BURST WHILE IN USE DUE TO THE STOMACH ACID. NO MISSING PIECES WERE OBSERVED.

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

  MAUDE report 10703606 ↗
• MalfunctionSep 18, 2020Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY BALLOON KEPT POPPED OUT AND SOMETIMES IT CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10553293 ↗
• MalfunctionApr 22, 2020Misassembled; Fluid/Blood Leak; Misassembled

  IT WAS REPORTED THAT THE PATIENT STATED HE HAS BEEN HAVING SOME LEAKAGE WITH HIS FOLEY CATHETER DUE TO THE EYELETS THAT WERE STRAIGHT ACROSS FROM EACH OTHER.

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

  MAUDE report 9985448 ↗
• MalfunctionOct 2, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE PATIENT THAT ONLY ONE SIDE OF THE BULB WOULD FILL/INFLATE ON THE FOLEY CATHETERS.

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

  MAUDE report 9145938 ↗
• MalfunctionNov 29, 2018Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE BARDEX IC FOLEY CATHETER WOULD NOT INFUSE.

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

  MAUDE report 8118565 ↗