Bardia® Foley Catheter Silicone Coated 123622ARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741095221), received between May 10, 2017 and Jun 26, 2024 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS LEAKING. EMERGENCY ROOM LIGHT WAS ON AND IT LEAKED AT NIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613751 ↗
• MalfunctionJun 24, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE STERILE WATER COULD NOT BE DRAINED FROM THE FOLEY CATHETER BALLOON DURING A PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594616 ↗
• MalfunctionMay 26, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CHEMO MEDICATION IT WAS SEEN POWER PICC CATHETER 5FR DL LUMEN CAP IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009560 ↗
• MalfunctionJun 2, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER SLIPPED OFF AND THE NURSE HAD CHECKED FOR ANY DAMAGE IN THE BALLOON. AND THE NURSE HAD CHANGED A NEW CATHETER TO THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 19MAY2022, IT WAS STATED THAT THE CATHETER SLIPPED OFF DUE TO THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579761 ↗
• MalfunctionMay 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347205 ↗
• MalfunctionSep 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIMES THE FOLEY CATHETERS DID NOT LAST AS LONG AS OTHERS INCLUDING THE LAST ONE THAT PATIENT HAD USED AND NO SPECIFICS WERE GIVEN. PER FOLLOW UP VIA PHONE ON 01SEP2021, CUSTOMER STATED THAT THE ONLY ISSUE WITH THE FOLEY CATHETERS WAS THAT OCCASIONALLY LEAKED AROUND WHERE THEY INSERTED THE CATHETER AND HAVE TO CHANGE THE CATHETER PREMATURELY, BUT CUSTOMER SAID IT MIGHT BE DUE TO THEIR BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519094 ↗
• MalfunctionNov 26, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LAST FOLEY CATHETER GOT CLOGGED UP.

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

  MAUDE report 10908560 ↗
• MalfunctionNov 18, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT WHEN ASKED ABOUT THE CHALLENGES THE HCP FACED WITH THE DEVICE, THE HCP MENTIONED "BALLONNET QUI A EXPLOSÉ SANS DÉPASSER LE NOMBRE LIMITE DE GONFLEMENT" MEANING "BALLOON THAT EXPLODED WITHOUT EXCEEDING THE LIMIT NUMBER OF INFLATION".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10863915 ↗
• InjuryFeb 21, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING FOR 2 OR 3 DAYS AFTER USING THE LATEX FOLEY CATHETER. PATIENT'S WIFE STATED THAT THE PATIENT EXPERIENCED BLEEDING AFTER USING THE LATEX CATHETER, WHICH RESULTED IN SWELLING OF PENIS/TISSUE, SORES AND BRUISES. PATIENT'S WIFE NOTICED THAT WHEN HER HUSBAND USED THE SILICONE COATED CATHETER PROVIDED BY THE HOSPITAL, HE DID NOT EXPERIENCE THE ISSUES. PATIENT WAS FOLLOWING UP WITH HIS DOCTOR. PER FOLLOW UP ON 19FEB2020, PATIENT WAS ADMITTED INTO THE HOSPITAL OVER THE WEEKEND REGARDING THE IRRITATION AND BLEEDING ( BLOOD CLOTS) DURING URINATION. THE PRIMARY CARE DOCTOR SWITCHED THE PATIENTS CATHETERS TO SILICONE DUE TO THE LATEX IRRITATION. PATIENT WAS STILL EXPERIENCING A LITTLE IRRITATION AND BLEEDING. PATIENT WAS CURRENTLY ON ANTIBIOTICS AND HAD BEEN RELEASED FROM THE HOSPITAL. ADDITIONAL INFORMATION REQUESTED REGARDING THE MEATUS TEAR A YEAR AGO, STATED THAT THE PERVIOUS CATHETER USED ON PATIENT WAS NOT A BD PRODUCT.

  Patient problems: Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding; Irritation; Pressure Sore/Ulcer; Swelling

  MAUDE report 9740191 ↗
• MalfunctionNov 26, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON POPPED WHILE INFLATING THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378555 ↗
• MalfunctionNov 26, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON POPPED WHILE INFLATING THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378547 ↗
• MalfunctionNov 26, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON POPPED WHILE INFLATING THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9374995 ↗
• MalfunctionAug 30, 2019Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING DIRECTLY INTO THE DRAIN BAG AND AS A RESULT ALLOWED FOR URINE LEAKAGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952227 ↗
• InjuryFeb 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CATHETERS WERE "BROWN" COMPARED TO THE OTHER CATHETERS THE PATIENT RECEIVED FROM ANOTHER COMPANY. THE PATIENT BELIEVES THE COLORING ON THE CATHETERS CAUSED A UTI. THE PATIENT WAS SEEN BY DOCTOR WHO PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8342684 ↗
• MalfunctionDec 18, 2018Partial Blockage; Partial Blockage; Blocked Connection

  IT WAS REPORTED THAT SOME OF THE PATIENT'S FOLEY CATHETERS KEPT GETTING PLUGGED UP. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE DEVICE WAS IN ABOUT 10 HOURS BEFORE THE CATHETER BEGAN TO CLOG. THE PATIENT INDICATED THAT THE CATHETER WAS BEING CLOGGED BY SEDIMENT FROM THE URINE. THE PATIENT HAD AN UPCOMING APPOINTMENT WITH HIS DOCTOR.

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

  MAUDE report 8173358 ↗
• MalfunctionAug 2, 2017No Flow

  IT WAS REPORTED THAT THE CATHETER STOPPED DRAINING.

  Patient problems: No Information

  MAUDE report 6761925 ↗
• MalfunctionAug 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, UPON INSERTION OF THE FOLEY CATHETER, NO URINE WOULD DRAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758500 ↗
• MalfunctionJul 17, 2017Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER FAILED TO INFUSE WHEN THE PATIENT ATTEMPTED TO INFLATE THE BALLOON AFTER INSERTION. A NEW CATHETER WAS OBTAINED AND USED WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720266 ↗
• MalfunctionMay 10, 2017Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER FAILED TO INFUSE.

  Patient problems: No Information

  MAUDE report 6556889 ↗