Bardia® Foley Catheter Silicone Coated 123512ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741095078), received between Mar 16, 2018 and Sep 28, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Difficult to Remove

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50923641 ↗
• InjurySep 28, 2026Inaccurate Flow Rate; Difficult to Remove

  It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. (Batch#MYLQ3401), (Batch#MYKZ3880). Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient, they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate. Patient 1 Batch# MYKZ3880. Batch# MYLQ3401.Patient 2 Batch# MYKZ3880. Batch# MYLQ3401.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916288 ↗
• InjurySep 28, 2026Difficult to Remove

  It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. (Batch#MYLQ3401, (Batch#MYKZ3880). Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient, they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate. Patient 1: Batch# MYKZ3880. Batch# MYLQ3401.Patient 2: Batch# MYKZ3880. Batch# MYLQ3401.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50916285 ↗
• InjurySep 25, 2026Inaccurate Flow Rate; Difficult to Remove

  It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient. they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899363 ↗
• InjurySep 10, 2026Material Puncture/Hole

  It was reported that the Patient was inserted with an IDC which could not be removed, and subsequently had to attend the ED for removal. Urine exposure.

  Patient problems: Exposure to Body Fluids

  MAUDE report 50717400 ↗
• MalfunctionAug 26, 2026Deflation Problem

  It was reported that during use, silicone IDC (Size 12) was found to be defective as the balloon could not be completely deflated prior to removal as a result, the IDC had to be removed by the Urologist while the foley catheter balloon was still partially inflated.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459573 ↗
• MalfunctionJan 23, 2026Difficult to Remove; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER PRODUCT DID NOT HAD DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172971 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, WATER LEAKED FROM THE OUTSIDE OF THE Y-SHAPED CONNECTION DURING FOLEY CATHETER BALLOON INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533582 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE THERE WAS BLACK FOREIGN MATTER INSIDE THE FOLEY CATHETER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289481 ↗
• MalfunctionAug 8, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURE DUE TO THIS CATHETER GOT LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751020 ↗
• MalfunctionJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT CLIENT CALLED HOMECARE TO REPORT THAT THEY HEARD A POP AND CATHETER FELL OUT. WHEN CLIENT ARRIVED AT CLINIC, FOLEY CATHETER WAS OUT BUT ATTACHED TO LEG BAG. WRITER COULD VISIBLY SAW A BREAK IN THE BALLOON MATERIAL ON THE CATHETER TIP. THE CATHETER WAS A BARDIA SILICONE ELASTOMER COATED 12FR 10 CC BALLOON. 1235 4SK069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496273 ↗
• MalfunctionMay 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER SLIPPED OUT AS THE BALLOON WAS BURST IN PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2025, STATED THAT THERE WAS PATIENT INVOLVED IN THE COMPLAINT. AFTER THE FOLEY FELL OFF, THE NURSE NOTICED INSTANTLY, AND THEY REPLACED BY THE FOLEY OF SAME MODEL. NO OTHER SPECIAL TREATMENT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987518 ↗
• MalfunctionJan 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT BARDIA SILICONE ELASTOMER COATED LATEX 2-WAY, 10ML FOLEY CATHETER, 12 FR BECAUSE OF NOT KNOWN, AND ALSO STATED THAT THE FOLEY CATHETER WAS NOT SUCCESSFULLY PLACED IN THE PATIENT FROM USE OF THIS PRODUCT BARDIA SILICONE ELASTOMER COATED LATEX 2-WAY, 10ML FOLEY CATHETER, 12 FR BECAUSE OF MISTAKE FROM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080122 ↗
• MalfunctionAug 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS BURST WHEN INFLATION WITH SALINE (NOT EXCEED THE MAXIMUM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918511 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 2 WAY URINARY FOLEY CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948502 ↗
• InjuryApr 12, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2023. ON 19TH MARCH 2023, THE NURSE DISCOVERED THAT THE CATHETER WAS DISLODGED DURING ROUTINE CARE. THE CATHETER WAS INSPECTED, THE BALLOON WAS COMPLETE BUT BURST. AS PER THE PHOTO SAMPLE RECEIVED, IT WAS FOUND THAT THE CATHETER BALLOON WAS BURST. STATED THAT THE USER WAS EXPOSED TO BLOOD, OR BODILY FLUIDS AND THE DETAILED EXPOSURE WAS URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16724062 ↗
• MalfunctionAug 19, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT NO URINE COULD BE DRAINED OUT BY USING THE FOLEY CATHETER TO THE URINE BAG. (DATE OF EVENT ON (B)(6) 2022). PER ADDITIONAL INFORMATION RECEIVED ON 08AUG2022, THEY WERE 2 MORE CASES USING THE SAME LOT HAVING THE SAME PROBLEM WHICH WAS FOUND TO BE BLOCKED AFTER BEING USED ON PATIENT (DATE OF EVENT ON (B)(6) 2022 AND DATE OF EVENT ON (B)(6) 2022). THE EVENT OCCURRED IN THREE DIFFERENT PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258569 ↗
• MalfunctionAug 19, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT NO URINE COULD BE DRAINED OUT BY USING THE FOLEY CATHETER TO THE URINE BAG. (DATE OF EVENT - (B)(6) 2022). PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THEY WERE 2 MORE CASES USING THE SAME LOT HAVING THE SAME PROBLEM WHICH WAS FOUND TO BE BLOCKED AFTER BEING USED ON PATIENT (DATE OF EVENT - (B)(6) 2022 AND DATE OF EVENT - (B)(6) 2022). THE EVENT OCCURRED IN THREE DIFFERENT PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258562 ↗
• MalfunctionAug 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT NO URINE COULD BE DRAINED OUT TO THE URINE BAG BY USING THE MENTIONED FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225635 ↗
• MalfunctionJun 21, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER BALLOON HAD LEAKED AND THE USER CHANGED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035505 ↗
• MalfunctionJan 21, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A DEFLATED BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610851 ↗
• MalfunctionDec 5, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WATER LEAKED FROM THE BALLOON ON THE FOLEY CATHETER CAUSING IT TO DEFLATE AND THE CATHETER FELL OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415745 ↗
• MalfunctionApr 7, 2019Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO DRAIN URINE OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490006 ↗
• MalfunctionSep 21, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING URINE.

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

  MAUDE report 7897516 ↗
• InjuryAug 2, 2018Break

  IT WAS REPORTED THAT THE FOLEY CATHETER BROKE AFTER INSERTION. THE FOLEY CATHETER WAS FILLED WITH 10 CC OF STERILE WATER AND THE CATHETER THEN FELL OUT OF THE PATIENT; HOWEVER, THE BALLOON WAS NO LONGER ATTACHED TO THE CATHETER. THE PATIENT WAS ADMITTED TO THE HOSPITAL; HOWEVER, IT IS UNKNOWN AT THIS TIME WHAT TREATMENT THE PATIENT RECEIVED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7741898 ↗