Bardex® All-Silicone Foley Catheter 166822Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741029837), received between Jun 15, 2020 and Mar 26, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A DEFECTIVE FOLEY. THE BALLOON WOULDN'T INFLATE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708521 ↗
• MalfunctionMar 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING UP, LEAKING AND CATHETER CAME OUT (PCN#166822). SOME CUSTOMERS REPORTED THAT SPLITTING ON THE SIDE OF THE DRAIN BAGS (PCN#154002).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617985 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT GOT AN INFECTION. CAREGIVER DID NOT SAY THE INFECTION WAS CAUSED BY THE FOLEY CATHETER. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21282289 ↗
• MalfunctionNov 23, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PHYSICIAN HAD ASKED IF THEY COULD GET DIFFERENT FOLEY BULBS TO REPLACE THOSE. DOCTOR SAID HOW MUCH THEY KNEW ABOUT HOW THEY USE THEM, BUT THOSE THEY DID NOT USE FOR BLADDER DRAINAGE. STATED THAT THOSE THEY USE IT TO INSERT INTO THE CERVIX BELOW THE BALLOON UP WITH FLUID AND MANUALLY DILATE THE CERVIX. THE PHYSICIAN THAT ASKED ABOUT THEM SAID IT WAS LIKE TRYING TO INSERT A COOKED SPAGHETTI NOODLE AND INQUIRED WHETHER THERE WERE ANY THAT WERE STIFFER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852633 ↗
• MalfunctionDec 23, 2020Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FOUND TO BE DISLODGED OR DISLOCATED. SUPPOSEDLY, THERE WERE NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Pain

  MAUDE report 11064651 ↗
• InjurySep 14, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT NOW HAD BLADDER CANCER FROM USING THE CATHETERS FOR SO MANY YEARS.

  Patient problems: Cancer; Patient Problem/Medical Problem

  MAUDE report 10532540 ↗
• InjurySep 1, 2020Inadequacy of Device Shape and/or Size; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SURGERY BECAUSE OF USING A WRONG CATHETER AND IT SHOULD BE 20FR, ALSO NO SPECIFICS REGARDING THE PROCEDURES WERE PROVIDED. IT WAS NOTED THAT PATIENT WAS PRESCRIBED WITH 22FR FOLEY. ALSO PATIENT WAS USING THE 22FR FOLEY SINCE (B)(6) 2018.

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 10477797 ↗
• MalfunctionAug 13, 2020Inflation Problem; Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON ON ONE OF THE FOLEYS THAT WAS RECEIVED LAST YEAR WOULD NOT STAY INFLATED FOR LONG.

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

  MAUDE report 10403609 ↗
• MalfunctionJun 15, 2020Partial Blockage; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS CLOGGED ON LAST CHANGE.

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

  MAUDE report 10155247 ↗