Bard® Clean-Cath® Intermittent Catheter 423714Recalls & reported problems
C. R. Bard, Inc. · Bard® Clean-Cath® Coude Olive Tip Urethral Catheter · Class 2
All models of Bard Clean-Cath Intermittent Catheter (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Clean-Cath intermittent catheter is a tube for draining urine through the urethra. The 25 reports mostly describe bent or twisted catheters that are hard to insert, with the guide mark not lining up with the tip, and rough or sharp surfaces mentioning pain, bleeding and discomfort, with no deaths and 1 injury. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741038877), received between Jul 11, 2017 and Oct 9, 2020 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (13 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
- Failure to Align13
- Difficult to Insert10
- Material Twisted/Bent7
- Scratched Material2
- Sharp Edges2
- Component Missing1
- Device Damaged Prior to Use1
- Improper Chemical Reaction1
Patient problems
- No Known Impact Or Consequence To Patient15
- Discomfort3
- No Information3
- No Patient Involvement3
- Hemorrhage/Blood Loss/Bleeding2
- Patient Problem/Medical Problem2
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2020Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION. ALSO STATED THAT THE URINARY TRACT INFECTION WAS DUE TO THE INTERMITTENT CATHETERS WOULD NOT HAD ENOUGH LUBRICANT AND THE PATIENT PUSHED THE CATHETER WHICH WAS TOO DRY. THE PATIENT HAD STOPPED USING THE CATHETER FOR A WHILE AND THIS WAS HAPPENED 9 MONTHS AGO. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED FOR THE URINARY TRACT INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10658754 ↗MalfunctionJul 17, 2020Scratched Material; Sharp Edges; Sharp Edges
IT WAS REPORTED BY THE PATIENT THAT THE CATHETER FELT A BIT ROUGH AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem
MAUDE report 10290271 ↗MalfunctionJun 15, 2020Sharp Edges; Scratched Material; Sharp Edges
IT WAS REPORTED THAT WHILE INSERTING THE CATHETER PATIENT FELT LIKE SHARP RAZOR BLADE AND ALSO EXPERIENCED PAIN. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Pain
MAUDE report 10155436 ↗MalfunctionJun 13, 2020Nonstandard Device; Nonstandard Device; Failure to Align; Material Twisted/Bent
IT WAS REPORTED THAT THE GUIDE DOT ON THE FUNNEL OF THE CLEAN CATH DOES NOT PROPERLY LINE UP TO THE COUDE TIP AND REMARKED THAT THIS HAS HAPPENED FOR 1 OUT OF 5 OF THE CATHETERS OUT OF EVERY BOX. PATIENT ALSO STATED THAT THERE WERE SOME THAT WERE TWISTED IN THE PACKAGE AND SUGGESTED THAT MIGHT BE WARPED FROM THE HEAT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10151341 ↗MalfunctionJun 11, 2020Failure to Align; Material Twisted/Bent
IT WAS REPORTED THAT THE GUIDE DOT ON THE FUNNEL OF THE CLEAN CATH DOES NOT PROPERLY LINE UP TO THE COUDE TIP AND REMARKED THAT THIS HAS HAPPENED FOR 1 OUT OF 5 OF THE CATHETERS OUT OF EVERY BOX. PATIENT ALSO STATED THAT THERE WERE SOME THAT WERE TWISTED IN THE PACKAGE AND SUGGESTED THAT MIGHT BE WARPED FROM THE HEAT.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10145685 ↗MalfunctionMar 27, 2020Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETERS WERE BENT, BUT THE PATIENT USED THEM ANYWAY WHICH CAUSED SELF-LIMITED BLEEDING. THE PATIENT WAS ABLE TO FULLY INSERT THE CATHETER AND VOID, BUT BLEEDING WAS NOTED. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem
MAUDE report 9892405 ↗MalfunctionOct 17, 2019Misassembled; Misassembled
IT WAS REPORTED THAT THE CATHETERS WERE MISSING THE EYELETS. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Discomfort
MAUDE report 9203317 ↗MalfunctionOct 16, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE TIPS OF THE CATHETERS WERE ROUGH, AND CAUSED DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort
MAUDE report 9197436 ↗MalfunctionMar 4, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SOME OF THE CATHETERS WERE NOT GOING ALL THE WAY IN. THE PATIENT STATED THAT IT FELT LIKE THERE WAS AN OBSTRUCTION. ADDITIONALLY, SOME OF THE CATHETERS WERE TWISTED AND CRINKLED UPON DELIVERY STRAIGHT OUT OF THE BOX. THE PATIENT'S WIFE ADVISED VIA PHONE ON (B)(6) 2019, THAT THEY RECEIVED THE REPLACEMENT CATHETERS FROM A DIFFERENT LOT AND THEY WERE WORKING MUCH BETTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8386974 ↗MalfunctionMar 4, 2019Difficult to Insert; Material Twisted/Bent
IT WAS REPORTED THAT SOME OF THE CATHETERS WERE NOT GOING ALL THE WAY IN. THE PATIENT STATED THAT IT FELT LIKE THERE WAS AN OBSTRUCTION. ADDITIONALLY, SOME OF THE CATHETERS WERE TWISTED AND CRINKLED UPON DELIVERY, STRAIGHT OUT OF THE BOX. THE PATIENT'S WIFE ADVISED VIA PHONE ON (B)(6)2019, THAT THEY RECEIVED THE REPLACEMENT CATHETERS FROM A DIFFERENT LOT AND THEY WERE WORKING MUCH BETTER. .
Patient problems: Discomfort; No Known Impact Or Consequence To Patient
MAUDE report 8386969 ↗MalfunctionJul 11, 2018Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER WAS TWISTED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7679524 ↗MalfunctionNov 3, 2017Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETERS WERE TWISTED.
Patient problems: No Information
MAUDE report 7000131 ↗MalfunctionNov 3, 2017Component Missing
IT WAS REPORTED THAT THERE WERE NO DRAIN EYES ON THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7000125 ↗MalfunctionNov 1, 2017Difficult to Insert
IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO INSERT. THE PATIENT WAS REPORTEDLY ONLY ABLE TO INSERT THE CATHETER PARTIALLY.
Patient problems: No Information
MAUDE report 6992739 ↗MalfunctionJul 12, 2017Failure to Align
IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION. AS A RESULT, THE DEVICE WAS UNABLE TO BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6709413 ↗MalfunctionJul 12, 2017Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION. AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Information
MAUDE report 6709412 ↗MalfunctionJul 12, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION. AS A RESULT, THE DEVICE WAS UNABLE TO BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6709403 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR THE INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704852 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NO BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704834 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704832 ↗MalfunctionJul 11, 2017Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704830 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704825 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704817 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704807 ↗MalfunctionJul 11, 2017Difficult to Insert; Failure to Align
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS MISALIGNED WITH THE DOT INDICATOR USED FOR INSERTION; AS A RESULT, THE DEVICE COULD NOT BE INSERTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6704287 ↗
Other CATHETER, UROLOGICAL devices
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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
- 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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