Bardia All-Silicone Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 13 models of Bardia All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2017 and Sep 18, 2026 — classified as 20 injuries, 121 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardia All-Silicone Foley Catheter problems
Device problems
- Deflation Problem19
- Burst Container or Vessel18
- Leak/Splash14
- Fluid/Blood Leak13
- Difficult to Remove12
- Decrease in Pressure11
- Material Puncture/Hole11
- Adverse Event Without Identified Device or Use Problem10
Patient problems
- No Consequences Or Impact To Patient54
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient49
- Urinary Tract Infection12
- Patient Problem/Medical Problem8
- Discomfort7
- Pain7
- Hemorrhage/Blood Loss/Bleeding6
Bardia All-Silicone Foley Catheter models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardia® All-Silicone Foley Catheter 806516CATHETER, RETENTION TYPE, BALLOON44 reports
- Bardia® All-Silicone Foley Catheter 806518CATHETER, RETENTION TYPE, BALLOON27 reports
- Bardia® All-Silicone Foley Catheter 806520CATHETER, RETENTION TYPE, BALLOON17 reports
- Bardia® All-Silicone Foley Catheter 806316CATHETER, RETENTION TYPE, BALLOON15 reports
- Bardia® All-Silicone Foley Catheter 806514CATHETER, URETHRAL10 reports
- Bardia® All-Silicone Foley Catheter 806522CATHETER, RETENTION TYPE, BALLOON7 reports
- Bardia® All-Silicone Foley Catheter 806318CATHETER, RETENTION TYPE, BALLOON5 reports
- Bardia® All-Silicone Foley Catheter 806524CATHETER, RETENTION TYPE, BALLOON5 reports
- Bardia® All-Silicone Foley Catheter 806320CATHETER, RETENTION TYPE, BALLOON3 reports
- Bardia® All-Silicone Foley Catheter 806324CATHETER, RETENTION TYPE, BALLOON3 reports
- Bardia® All-Silicone Foley Catheter 806510CATHETER, UROLOGICAL2 reports
- Bardia® All-Silicone Foley Catheter 806512CATHETER, RETENTION TYPE, BALLOON2 reports
- Bardia® All-Silicone Foley Catheter 806508CATHETER, UROLOGICAL1 report
Recent Bardia All-Silicone Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819875 ↗MalfunctionAug 3, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110030 ↗MalfunctionFeb 18, 2026Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED BY CUSTOMER THAT THEY HAD A DEFECT ON THE PRODUCT, AND THE CATHETER WAS INSERTED ON THE PATIENT AND WITHIN A COUPLE DAYS IT WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381328 ↗MalfunctionNov 13, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT CUSTOMER STATED THAT THE CATHETER BALLOON WON'T DEFLATE WHEN THEY ARE TRYING TO REMOVE THE CATHETER FROM THE BLADDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541955 ↗MalfunctionOct 17, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE CUSTOMER STATED 3 OF THE CATHETERS IN THE LAST ORDER HAD A HOLE IN THE BALLOON AND THEY ARE ASKING FOR US TO SEND REPLACEMENT CATHETERS OUT TO THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322319 ↗MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A COMPLAINT FROM A PATIENT STATING THAT FOLEY'S CATHETERS RECEIVED WERE DEFECTIVE. THE FOLEY WAS LEAKING WHERE IT CONNECTS TO THE BAG. LOT NUMBER WAS NOT AVAILABLE DUE TO THROWING AWAY PACKAGING AFTER OPENING. THEY WERE EXPERIENCED ISSUES WITH 2 FOLEY CATHETER AND THEY HAVE ONE UNOPENED PRODUCT ON HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095864 ↗MalfunctionSep 4, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DOES NOT HOLD IT WAS LIKE A FINE MIST, WILL ONLY HOLD FOR 6 TO 8 HOURS BEFORE HAVING TO CHANGE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963721 ↗MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PATIENT SAID FIRST TIME ONE FOLEY CATHETER WAS LEAKED. IT WAS 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 22938341 ↗MalfunctionJul 25, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE, THE BALLOON DEFLATED WHICH CAUSED THE CATHETER TO SLID OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22620908 ↗MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CATHETER WAS LEAKING WHILE USING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132475 ↗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 12, 2025Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED BY THE CRITICAL CARE NURSE IN THE ONLINE SURVEY THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT ALL-SILICONE FOLEY CATHETER, 2-WAY, STANDARD LENGTH, 5CC BALLOON, 20 FR BECAUSE OF 3 WAY CATHETER INSERTED AND IRRIGATION COMMENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363683 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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