Bardia® All-Silicone Foley Catheter 806514Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741039164), received between Oct 30, 2019 and Mar 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURSTS SHORTLY AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652972 ↗
• MalfunctionFeb 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER HAD A PIN HOLE AT THE Y CONNECTOR. SALINE WAS COMING OUT. LOT#NGJW3118. FOLEY CATHETER BALLOON WOULD NOT DEFLATE LOT#NGJT2607. BALLOON WOULD NOT DEFLATE LOT#NGJS5070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333374 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER HAD A PIN HOLE AT THE Y CONNECTOR. SALINE WAS COMING OUT. LOT # NGJW3118. FOLEY CATHETER BALLOON WOULD NOT DEFLATE. LOT # NGJT2607. BALLOON WOULD NOT DEFLATE LOT# NGJS5070. PER CUSTOMER VIA EMAIL ON 04MAR2025, IT WAS REPORTED THAT LOT # NGJW3118 ITEM # 806514 CUSTOMER STATED THAT THE BARD FOLEY HAD A PINHOLE IN IT AT THE Y CONNECTOR. SALINE WAS CAME OUT. THEY WENT TO TEST THE FOLEY SECUREMENT, AND IT CAME OUT. BALLOON WAS DEFLATED. LOT# FOR THE AFFECTED 2, 1 WITH BALLOON WOULD NOT DEFLATE. LOT# NGJS5070. OR LOT# NGJT2607. NOT SURE WHAT PACKAGE EITHER FOLEY WAS PULLED OUT OF. THE OTHER ONE THAT CUSTOMER DID NOT KNOW WHAT WAS WRONG WITH IT WAS THE 5070 LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333373 ↗
• MalfunctionFeb 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER HAD A PIN HOLE AT THE Y CONNECTOR. SALINE WAS COMING OUT. LOT#NGJW3118. FOLEY CATHETER BALLOON WOULD NOT DEFLATE. LOT#NGJT2607. BALLOON WOULD NOT DEFLATE LOT#NGJS5070. PER CUSTOMER VIA EMAIL ON (B)(6) 2025, IT WAS REPORTED THAT LOT# NGJW3118 ITEM# 806514 CUSTOMER STATED THAT THE BARD FOLEY HAD A PINHOLE IN IT AT THE Y CONNECTOR. SALINE WAS CAME OUT. THEY WENT TO TEST THE FOLEY SECUREMENT, AND IT CAME OUT. BALLOON WAS DEFLATED. LOT# FOR THE AFFECTED 2, 1 WITH BALLOON WOULD NOT DEFLATE. LOT# NGJS5070. OR LOT# NGJT2607. NOT SURE WHAT PACKAGE EITHER FOLEY WAS PULLED OUT OF. THE OTHER ONE THAT CUSTOMER DID NOT KNOW WHAT WAS WRONG WITH IT WAS THE 5070 LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333372 ↗
• MalfunctionJan 31, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEYS CATHETER THAT SHIPPED ON JAN2024 WERE PAINFUL UPON INSERTION, TIPS NOT AS ROUNDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21282286 ↗
• MalfunctionApr 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT RECEIVED THREE CATHETERS ON MOST RECENT ORDER, THE FIRST ONE WAS USED SUNDAY NIGHT AND ON MONDAY MORNING THE CATHETER HAD COME OUT, THEY STATED THERE WAS A PINHOLE AT THE TOP OF THE Y WHERE THE FOLEY MEETS THE Y. THE SECOND FOLEY INFLATED BUT WILL NOT RELEASE THE WATER. CAREGIVER WAS NOW ON THIRD CATHETER AND THIRD INSERTION TRAY DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213781 ↗
• MalfunctionSep 5, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682098 ↗
• MalfunctionFeb 18, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON DID NOT INFLATE.

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

  MAUDE report 11345913 ↗
• MalfunctionMay 27, 2020Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT HOLD WATER.

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

  MAUDE report 10092513 ↗
• MalfunctionOct 30, 2019Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE CATHETER BECAME CLOGGED AFTER 2 WEEKS OF USE, AND THE CUSTOMER WAS UNABLE TO FLUSH IT SO IT WAS REMOVED AND REPLACED. THE CUSTOMER NOTED THAT THE CATHETER BECAME CLOGGED FROM A BUILD OF THE INTERIOR COATING OF THE CATHETER.

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

  MAUDE report 9257269 ↗