Pop-On Self-Adhering Male External CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 9 models of Pop-On Self-Adhering Male External Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2017 and Mar 20, 2023 — classified as 4 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (16 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
Most reported Pop-On Self-Adhering Male External Catheter problems
Device problems
- Nonstandard Device16
- Difficult to Remove4
- Physical Resistance/Sticking3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Material Integrity Problem2
- Patient-Device Incompatibility2
- Product Quality Problem2
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient7
- Discomfort2
- Rash2
- Reaction2
- Skin Inflammation/ Irritation2
- Skin Tears2
Pop-On Self-Adhering Male External Catheter models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pop-On™ Self-Adhering Male External Catheter 32302DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE10 reports
- Pop-On™ Self-Adhering Male External Catheter 32305DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE4 reports
- Pop-On™ Self-Adhering Male External Catheter 32303DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE3 reports
- Pop-On™ Self-Adhering Male External Catheter 32104DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE2 reports
- Pop-On™ Self-Adhering Male External Catheter 32301DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE2 reports
- Pop-On™ Self-Adhering Male External Catheter 32102DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE1 report
- Pop-On™ Self-Adhering Male External Catheter 32103DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE1 report
- Pop-On™ Self-Adhering Male External Catheter 32105DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE1 report
- Pop-On™ Self-Adhering Male External Catheter 32304DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE1 report
Recent Pop-On Self-Adhering Male External Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE ADHESIVE MADE IT DIFFICULT TO APPLY AND REMOVE THE MALE EXTERNAL CATHETER . THE PATIENT¿S HAIR GOT CAUGHT IN THE ADHESIVE CAUSING PAIN. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16578477 ↗MalfunctionAug 8, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUE WITH ADHESIVE ON MALE EXTERNAL CATHETERS AND REPRESENTATIVE GAVE SOME TROUBLE SHOOTING TIPS ON REMOVING ADHESIVE WITH WARM WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15185080 ↗MalfunctionAug 3, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY HARD TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15160214 ↗InjuryJun 21, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER PULL THE SKIN OFF OF THE PATIENT PENIS. DOCTOR TOLD THE PATIENT THAT THE CATHETER WAS TOO STICKY AND WAS CAUSING SORES, A RASH AND THE SKIN TO TEAR. PATIENT HAD HEALED SINCE THEY WERE NOT USING. PATIENT HAD BEEN WEARING DIAPERS. PATIENT HAD NURSE COMING TO HOME AND WAS PROVIDED SKIN PREPPING SPRAY.
Patient problems: Rash; Skin Inflammation/ Irritation; Skin Tears
MAUDE report 14757720 ↗MalfunctionMay 13, 2022Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE PRODUCT EXPIRATION DATE DIFFERED FROM THE BEST-BEFORE DATE ON THE CARTON/LABEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397626 ↗MalfunctionApr 12, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY USING MALE EXTERNAL CATHETER WITH ADHESIVE. STATED THAT SOME CATHETERS WERE STUCK CLOSED AND ADHESIVE IN SOME CATHETERS WERE TOO AGGRESSIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14086753 ↗MalfunctionMar 25, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER GOT STUCK ON AND IT WAS VERY HARD TO COME OFF WHICH CAUSED AN IRRITATION TO PATIENT'S SKIN. NO MEDICAL INTERVENTION REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 11569333 ↗MalfunctionDec 8, 2020Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT PATIENT SAID THAT MALE EXTERNAL CATHETER ORDER HAD TOO MUCH ADHESIVE IN THE LAST BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10972415 ↗MalfunctionDec 1, 2020Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE IN THE MALE EXTERNAL CATHETER AND TEARING SKIN. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Skin Tears
MAUDE report 10929264 ↗MalfunctionOct 27, 2020Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO STICKY AND ALSO STATED THAT IT WAS PULLING WITH LITTLE MOISTURE ON THE SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10741923 ↗MalfunctionAug 14, 2020Nonstandard Device; Difficult to Remove; Physical Resistance/Sticking; Nonstandard Device
IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STICKY AND DIFFICULT TO REMOVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10407696 ↗InjuryApr 2, 2020Backflow; Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT ENDED UP WITH AN INFECTION DUE TO URINE THAT BACKED UP INTO THE MALE EXTERNAL CATHETER.
Patient problems: Unspecified Infection; Urinary Tract Infection
MAUDE report 9918357 ↗MalfunctionMar 21, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS EXTREMELY HARD TO COME OFF. THE PATIENT HAD REPORTEDLY TRIED A WARM CLOTH AND HOT SHOWER AS ADVISED WITH NO REMEDY. THE PATIENT STATED THE LAST CATHETER HE USED, HE HAD TO REMOVE IT WITH A PAIR OF SCISSORS.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9863583 ↗InjuryDec 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MEC SHEATHS CAUSED THE USER TO HAVE A SKIN REACTION. ONCE HEALED THE PATIENT TRIED THE PRODUCT AGAIN, WHICH RESULTED IN A MORE SEVERE REACTION OF REDNESS, SORENESS, BLISTERS AND PEELING SKIN. THE GENERAL PRACTITIONER ADVISED HIM TO DISCONTINUE USE.
Patient problems: Reaction; Skin Irritation; Swelling
MAUDE report 9507809 ↗MalfunctionDec 19, 2019Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking
IT WAS REPORTED THAT THE MEC SHEATH WAS NOT ABLE TO BE ROLLED DOWN. PER EMAIL ATTACHED, THE MEC ADHERES TO THE PATIENT'S PENIS CAUSING DISCOMFORT UPON REMOVAL.
Patient problems: Discomfort
MAUDE report 9497568 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page