Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314Recalls & reported problems

C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Bard Lubri-Sil Foley catheter is a silicone urinary tube. Reports often describe holes in the tube, balloons that do not deflate and fluid leaks. The 3,843 reports include 29 injuries and no deaths. There is 1 open recall, started in June 2025, because the tube may become blocked and stop urine draining from the bladder. Reports fell to 221 in the last 12 months from 1,410 in the previous 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 3,889
Deaths reported: 0
Injuries reported: 31
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3,889 adverse event reports that list this exact device (DI 00801741039843), received between Apr 19, 2017 and Sep 30, 2026 — classified as 31 injuries, 3,858 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1,384 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jun 18, 2025Class IIOpen, Classified
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Z-2462-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Device problems

Material Puncture/Hole1,384
Deflation Problem640
Difficult to Remove528
Fluid/Blood Leak495
Decrease in Pressure280
Component Misassembled193
Failure to Infuse185
Inflation Problem169

Patient problems

No Clinical Signs, Symptoms or Conditions3,330
No Known Impact Or Consequence To Patient405
No Consequences Or Impact To Patient319
No Patient Involvement217
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available56
Pain8
Discomfort7
No Information7

Recent adverse event reports

The 25 most recent of 3,889 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952607 ↗
MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926184 ↗
MalfunctionSep 23, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873312 ↗
MalfunctionSep 22, 2026Material Rupture
It was reported that during use, 2 hours after placement, the foley catheter used in the operating room fell out in the Intensive Care Unit (ICU). There is no indication that any device parts remained in the body after the balloon ruptured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855631 ↗
InjurySep 21, 2026Difficult to Remove
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50848696 ↗
MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829602 ↗
MalfunctionSep 18, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829600 ↗
MalfunctionSep 18, 2026Calcified
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819877 ↗
MalfunctionSep 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781993 ↗
MalfunctionSep 14, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765282 ↗
MalfunctionSep 11, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741620 ↗
MalfunctionSep 10, 2026Difficult to Remove
It was reported that during placement the foley catheter took a long time to drain fluid when removing the catheter. Was able to drain the entire volume after spending some time (Approximately 15 minutes).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717393 ↗
MalfunctionSep 2, 2026Fluid/Blood Leak
It was reported that used during a procedure in the cardiac catheterization lab. Sterile water leaked from the catheter's valve section.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566241 ↗
MalfunctionSep 2, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50562029 ↗
MalfunctionAug 26, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459571 ↗
MalfunctionAug 26, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456186 ↗
MalfunctionAug 26, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456184 ↗
MalfunctionAug 26, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456183 ↗
MalfunctionAug 26, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456182 ↗
MalfunctionAug 26, 2026Material Puncture/Hole
It was reported that after being placed in OP, it was discovered that the foley catheter had come out in the ward. Similar cases occur frequently. Natural drainage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456181 ↗
MalfunctionAug 26, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456179 ↗
MalfunctionAug 21, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50377858 ↗
MalfunctionAug 19, 2026Material Rupture
It was reported that spontaneous detachment due to leak in the balloon section.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329555 ↗
MalfunctionAug 19, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50319309 ↗
MalfunctionAug 17, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280938 ↗

Device details

UDI-DI	`00801741039843`
Brand	Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter
Model	119314
Company	C. R. Bard, Inc.
Product code	MJC · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Dec 4, 2020

Device type (GMDN): Indwelling urethral drainage balloon catheter, antimicrobial

A flexible tube with an inflatable balloon on its distal tip intended to be inserted through the urethra and retained in the urinary bladder of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage. It is used for a variety of conditions causing urinary retention (e.g., postoperative, obstruction). Commonly known as a Foley catheter, it is inserted by trained staff and may have a bent tip (coude) to facilitate insertion. It is also coated with an antibiotic or antimicrobial agent to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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