Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70522SIRecalls & reported problems

C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. All-Silicone Coated 5 cc 3 way Foley Catheter · Class 2

All models of Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (26)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741025464), received between Oct 11, 2021 and Apr 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (2 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.

Reports received per month

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

Most reported problems

Device problems

Inability to Irrigate2
Material Puncture/Hole2

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 15, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED CUSTOMER HAVING AN EXTREME ISSUE WITH ALL OUR 3-WAY FOLEY CATHETERS LEAKING WITH PIN HOLES AT THE BASE OF THE 3 WAYS. THE TWO THAT THEY HAD CURRENTLY WEREAND, THE TEAM SAID THAT THEY SINCE THIS HAPPENED, THEY TRY THEM OUT FIRST. THE TEAM SAID THEY WENT THROUGH AT LEAST 7 IN TWO DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21840863 ↗
MalfunctionApr 15, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT CUSTOMER HAD AN EXTREME ISSUE WITH ALL THEIR 3-WAY FOLEY CATHETERS LEAKING WITH PIN HOLES AT THE BASE OF THE 3 WAYS. THE TWO THAT THEY HAD CURRENTLY WERE 73024SI AND 70522SI, THE TEAM SAID THAT THEY SINCE THIS HAPPENED, THEY TRY THEM OUT FIRST. THE TEAM SAID THEY WENT THROUGH AT LEAST 7 IN TWO DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21839789 ↗
MalfunctionOct 22, 2021Inability to Irrigate; Inability to Irrigate
IT WAS REPORTED THAT TWO OF THE FOLEY CATHETERS WOULD NOT ALLOW CONSTANT IRRIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12683778 ↗
MalfunctionOct 11, 2021Inability to Irrigate; Inability to Irrigate
IT WAS REPORTED THAT THE DRAIN BAG NEEDED PORTS. REPRESENTATIVE ADVISED THAT THEY WOULD EXCHANGE THE BAGS. PATIENT ALSO STATED THAT THE FOLEY CATHETERS DID NOT ALLOW CONSTANT IRRIGATION. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605657 ↗

Device details

UDI-DI	`00801741025464`
Brand	Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter
Model	70522SI
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	Labeling does not contain MRI Safety Information
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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All CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices →

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
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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