Bard® Touchless® Urethral Catheter Kit With Red Rubber Catheter 4A3053Recalls & reported problems
C. R. Bard, Inc. · Bard® Touchless® Urethral Catheter Kit With Red Rubber Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Touchless urethral catheter kit is a sterile tray holding a red rubber catheter for draining the bladder. The 31 reports mostly describe kits arriving with missing parts — most often no lubricating jelly or iodine gel in the tray — plus a few leaking or bursting packages and one catheter of the wrong size. No deaths and no injuries are reported, and most reports say no patient was involved. No recalls name this device.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741030680), received between Jul 28, 2017 and Dec 9, 2020 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Component Missing” (28 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
Device problems
- Component Missing28
- Burst Container or Vessel2
- Gel Leak2
- Inadequacy of Device Shape and/or Size1
- No Apparent Adverse Event1
Patient problems
- No Patient Involvement30
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions8
- No Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT JELLY OR IODINE'S WAS MISSING FROM 12 BARD TOUCHLESS CATHETER IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10978028 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT JELLY OR IODINE'S WAS MISSING FROM 12 BARD TOUCHLESS CATHETER IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10978024 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE BARD TOUCH LESS CATHETER HAVING MISSING IODINE IN THE LAST COUPLE OF MONTHS. THE CUSTOMER WAS USING BARD TOUCH LESS FOR 18 YEARS AND THIS HAS BEEN HAPPENED A FEW TIMES, BUT NEVER REPORTED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977915 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE BARD TOUCH LESS CATHETER HAVING MISSING IODINE IN THE LAST COUPLE OF MONTHS. THE CUSTOMER WAS USING BARD TOUCH LESS FOR 18 YEARS AND THIS HAS BEEN HAPPENED A FEW TIMES, BUT NEVER REPORTED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977914 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT JELLY OR IODINE'S WAS MISSING FROM 12 BARD TOUCHLESS CATHETER IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977909 ↗MalfunctionDec 9, 2020Component Missing; No Apparent Adverse Event; Component Missing; No Apparent Adverse Event
IT WAS REPORTED THAT JELLY OR IODINE'S WAS MISSING FROM 12 BARD TOUCHLESS CATHETER IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977908 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT JELLY OR IODINE'S WAS MISSING FROM 12 BARD TOUCHLESS CATHETER IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977907 ↗MalfunctionDec 9, 2020Component Missing; Component Missing
IT WAS REPORTED THAT 12 BARD TOUCHLESS CATHETER WAS HAVING MISSING JELLY OR IODINE'S IN THE LAST COUPLE OF MONTHS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10977903 ↗MalfunctionAug 20, 2020Component Missing
IT WAS REPORTED THAT 7 BARD TOUCHLESS CATHETERS DID NOT HAVE JELLY OR IODINE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10431836 ↗MalfunctionAug 20, 2020Component Missing
IT WAS REPORTED THAT 7 BARD TOUCHLESS CATHETERS DID NOT HAVE JELLY OR IODINE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10431824 ↗MalfunctionJul 22, 2020Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE RED RUBBER CATHETERS IN THE KITS WERE SMALLER AND SOME WERE BIGGER. PER FOLLOW UP ON 23JUL2020, THE CUSTOMER NOTED THAT SOME OF THE CATHETERS IN THE KIT WERE SMALLER THAN 14FR. THE CATHETER WAS MORE FLEXIBLE WHEN SMALLER AND RESULTED IN BENDING DURING INSERTION.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10309244 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9136282 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9136279 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON (B)(6) 2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9136276 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9136272 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9135711 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES HAVE BEEN MISSING IN THE LAST COUPLE MONTHS IN 7 BARD TOUCHLESS CATHETERS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9135708 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9135617 ↗MalfunctionSep 30, 2019Component Missing
IT WAS REPORTED THAT THE CUSTOMER STATED THE JELLY OR IODINES IN 7 BARD TOUCHLESS CATHETERS HAVE BEEN MISSING IN THE LAST COUPLE MONTHS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA EMAIL ON 12SEP2019, HE WAS NOT SURE WHICH CATHETERS WERE MISSING IODINE OR JELLY.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9135602 ↗MalfunctionFeb 19, 2019Burst Container or Vessel; Gel Leak; Gel Leak
IT WAS REPORTED THAT THE IODINE "BUSTED" IN THE KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8350608 ↗MalfunctionFeb 19, 2019Component Missing
IT WAS REPORTED THAT THE LUBRICANT JELLY WAS MISSING FROM THE TOUCHLESS KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8350604 ↗MalfunctionFeb 19, 2019Component Missing
IT WAS REPORTED THAT THE LUBRICANT JELLY WAS MISSING FROM THE TOUHLESS KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8350549 ↗MalfunctionFeb 19, 2019Burst Container or Vessel; Gel Leak; Gel Leak
IT WAS REPORTED THAT THE IODINE "BUSTED" IN THE KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8350523 ↗MalfunctionFeb 19, 2019Component Missing
IT WAS REPORTED THAT THE LUBRICANT JELLY WAS MISSING FROM THE TOUCHLESS KIT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8350521 ↗MalfunctionSep 13, 2018Component Missing
IT WAS REPORTED THAT THE KIT WAS MISSING THE IODINE PACKETS. THE PATIENT ALLEGED THAT HE HAD RECEIVED THIS CATHETER PRIOR TO THE PVI SHORTAGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7874198 ↗
Other Tray, catheterization, sterile urethral, with or without catheter (kit) devices
- Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5144C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)170 reports
- Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A7044C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)54 reports
- Dover 3450LFCardinal Health, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall3 reports
- Dover 3450Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall1 report
- Dover 3410Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600784Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600776Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3408Cardinal Health 200, LLC · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 reports
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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