UltraFlex Self-Adhering Male External CatheterRecalls & reported problems across all models

We found 9 models of UltraFlex Self-Adhering Male External Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2017 and May 8, 2024 — classified as 13 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (59 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 UltraFlex Self-Adhering Male External Catheter problems

UltraFlex Self-Adhering Male External Catheter models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• UltraFlex™ Self-Adhering Male External Catheter 33302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  31 reports
• UltraFlex™ Self-Adhering Male External Catheter 33303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  22 reports
• UltraFlex™ Self-Adhering Male External Catheter 33103

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  20 reports
• UltraFlex™ Self-Adhering Male External Catheter 33301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  14 reports
• UltraFlex™ Self-Adhering Male External Catheter 33102

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  5 reports
• UltraFlex™ Self-Adhering Male External Catheter 33305

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  5 reports
• UltraFlex™ Self-Adhering Male External Catheter 33104

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  4 reports
• UltraFlex™ Self-Adhering Male External Catheter 33304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  3 reports
• UltraFlex™ Self-Adhering Male External Catheter 33101

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports

Recent UltraFlex 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.

• InjuryMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER WAS LEAKING AND CAUSING ISSUE WITH THEIR WOUNDS. THEY WENT TO WOUND CLINIC ON (B)(6) TO GET THEIR WOUNDS CLEANED AS THE LEAKAGE WAS CAUSING INFECTIONS. PER SAMPLE RECEIVED ON (B)(6) 2024, THE CUSTOMER HAD RETURNED ADDITIONAL SAMPLE WITH BATCH NUMBER JUHY1564. PER SAMPLE FORM RECEIVED ON 22APR2024, IT WAS REPORTED THAT THE PATIENT TRIED THREE OF THE CATHETERS FROM LOT#JUHY1564 AND ONE FROM LOT#JUHY0636. ALL FOUR LEAKED OVERNIGHT AND PATIENT WAS DRENCHED IN URINE CAUSING TO THE WOUNDS AND WENT INTO THE HOSPITAL FROM (B)(6) 2024, FOUND OUT WOUND INFECTED FROM THE URINE. PATIENT WAS TREATED ON INTRAVENOUS TOXIN ANTIBIOTIC FOR 10 DAYS TO CLEAR BACTERIAL INFECTION.

  Patient problems: Bacterial Infection; Tissue Breakdown

  MAUDE report 19268925 ↗
• InjuryMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER WAS LEAKING AND CAUSING ISSUE WITH THEIR WOUNDS. THEY WENT TO WOUND CLINIC ON 21MAR TO GET THEIR WOUNDS CLEANED AS THE LEAKAGE WAS CAUSING INFECTIONS. PER SAMPLE RECEIVED ON 22APR2024, THE CUSTOMER HAD RETURNED ADDITIONAL SAMPLE WITH BATCH NUMBER JUHY1564. PER SAMPLE FORM RECEIVED ON 22APR2024, IT WAS REPORTED THAT THE PATIENT TRIED THREE OF THE CATHETERS FROM LOT#JUHY1564 AND ONE FROM LOT#JUHY0636. ALL FOUR LEAKED OVERNIGHT AND PATIENT WAS DRENCHED IN URINE CAUSING TO THE WOUNDS AND WENT INTO THE HOSPITAL FROM (B)(6) 2024, FOUND OUT WOUND INFECTED FROM THE URINE. PATIENT WAS TREATED ON INTRAVENOUS TOXIN ANTIBIOTIC FOR 10 DAYS TO CLEAR BACTERIAL INFECTION.

  Patient problems: Bacterial Infection; Tissue Breakdown

  MAUDE report 19268451 ↗
• MalfunctionAug 24, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED EXPIRED PRODUCT AND USED A COUPLE ALREADY. ALSO STATED THAT THEY WERE NOT STICKING. THEY WOULD LIKE TO KNOW IF BD MADE A SIZE BETWEEN 25-29. PER CUSTOMER VIA PHONE ON (B)(6) IT WAS REPORTED THAT THE EXPIRATION DATE WAS LISTED AS FEB-2019. THE CUSTOMER RECEIVED THE MALE EXTERNAL CATHETERS THROUGH THE VETERANS HEALTH ADMINISTRATION, AND THEY WOULD REACH OUT TO THEM IN ORDER TO COORDINATE REPLACEMENT UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611742 ↗
• MalfunctionJan 3, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE STICKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086164 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GETTING URINARY TRACT INFECTIONS BUT WAS NOT SURE WHETHER IT WAS FROM THE CONDOM CATHETERS. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTIONS AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN. AS PER CUSTOMER VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT PATIENT DID HAVE AN URINARY TRACT INFECTIONS TWICE AND WAS PRESCRIBED ANTIBIOTICS TWICE FROM THEIR DOCTOR.

  Patient problems: Urinary Tract Infection

  MAUDE report 15494208 ↗
• MalfunctionAug 11, 2022Inaccurate Flow Rate; Device Handling Problem; Inaccurate Flow Rate; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTIES WITH MALE EXTERNAL CATHETER. STATED THAT WHEN THE PATIENT URINATES, THE URINE STAYED INSIDE THE TIP OF THE CATHETER AND WOULD NOT FLOW DOWN THE TUBING AND INTO THE BAND AND CAUSED LEAKAGE AND SAID IT SEEMED LIKE THERE WAS A POCKET OF AIR AND THE URINE WOULD NOT FLOW. INQUIRER CONFIRMED THAT THE PATIENT HAD BEEN CONNECTING THE BAG AND TUBING TO THE MALE EXTERNAL CATHETER PRIOR TO PLACING THE CATHETER ON THE PENIS AND IT DID NOT FEEL LIKE THE PATIENT GOT A GOOD GRIP FROM THE ADHESIVE ON THE CATHETER AND ALSO DISCUSSED WAYS TO PREVENT AIR LOCK, PUT THE CATHETER ON FIRST THEN CONNECTED THE TUBING OR BAG TO THE TIP AND EXERCISING THE BAG PRIOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208874 ↗
• MalfunctionMay 12, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NEW BATCH OF MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE. PATIENT WAS NORMALLY ABLE TO REMOVE USING A WARM COMPRESS BUT WITH THIS BATCH THEY HAD TO USE ALCOHOL AND A COTTON SWAB TO GET THE CATHETER OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376394 ↗
• MalfunctionMay 3, 2022Nonstandard Device; Patient Device Interaction Problem; Nonstandard Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER (MEC) WAS VERY STICKY. THE PATIENT HAD BEEN USING THE MEC PRODUCTS FOR MORE THAN 90 DAYS. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, THE PATIENT¿S WIFE REPORTED THE MALE EXTERNAL CATHETERS WERE TOO STICKY TO USE. THREE OF THE PRODUCTS STUCK TO THEMSELVES WHEN THEY WERE REMOVED FROM THE PACKAGE. THE FOURTH MEC ADHERED TO THE PATIENT WHEN APPLIED AND CAUSED PAIN. THE PATIENT'S WIFE ALSO REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2022 DUE TO SEPSIS. A CLINICAL FOLLOW UP CALL WAS PLACED ON (B)(6) 2022, BUT THE PATIENT¿S WIFE DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION AND REQUESTED NOT TO BE CONTACTED AGAIN. THERE WAS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH.

  Patient problems: Pain

  MAUDE report 14269812 ↗
• InjuryApr 21, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS NOT ADHERING AND FALLING OFF. STATED THAT THEY HAD TROUBLE FITTING THE CATHETER, HAD BLEEDING FROM BLADDER AND HAD A BLADDER CANCER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14166721 ↗
• MalfunctionMar 24, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS TRYING OUT MALE EXTERNAL CATHETERS AND HAVE TRIED TWO TYPES BUT BOTH WERE INCONSISTENTLY STAYING IN PLACE THROUGH THE NIGHT. CUSTOMER MENTIONED THAT THEY HAVE STAYED ON 2 OUT OF 5 NIGHTS (LOT: JUFV2649 & LOT: JUFX2803). INQUIRER REVIEWED THE DIRECTION FOR USE WITH THE CUSTOMER AND FOUND THAT THEY WERE APPROPRIATELY APPLYING THE CATHETER. CUSTOMER REPORTED THAT THEY CLEANED THE PENIS WITH SOAP AND WATER, THOROUGHLY DRIED IT AND APPLIED THE CATHETER SO THAT IT HAD A LIMITED NUMBER OF WRINKLES AND TRIED TO SQUEEZE IT SO THAT THE ADHESIVE STUCK TO THE SKIN. CUSTOMER ALSO REPORTED THAT THE LARGER OF THE TWO CATHETERS SEEMED TO FIT THE PATIENT BETTER BUT SAID THAT IT EVEN CAME OFF AND ALSO NOTED THAT SOME CATHETERS SEEMED TO BE MORE STICKY THAN OTHERS (LOT: JUFV2649 & LOT: JUFX2803).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873490 ↗
• MalfunctionMar 24, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS TRYING OUT MALE EXTERNAL CATHETERS AND HAVE TRIED TWO TYPES BUT BOTH WERE INCONSISTENTLY STAYING IN PLACE THROUGH THE NIGHT. CUSTOMER MENTIONED THAT THEY HAVE STAYED ON 2 OUT OF 5 NIGHTS (LOT: JUFV2649 & LOT: JUFX2803). INQUIRER REVIEWED THE DIRECTION FOR USE WITH THE CUSTOMER AND FOUND THAT THEY WERE APPROPRIATELY APPLYING THE CATHETER. CUSTOMER REPORTED THAT THEY CLEANED THE PENIS WITH SOAP AND WATER, THOROUGHLY DRIED IT AND APPLIED THE CATHETER SO THAT IT HAD A LIMITED NUMBER OF WRINKLES AND TRIED TO SQUEEZE IT SO THAT THE ADHESIVE STUCK TO THE SKIN. CUSTOMER ALSO REPORTED THAT THE LARGER OF THE TWO CATHETERS SEEMED TO FIT THE PATIENT BETTER BUT SAID THAT IT EVEN CAME OFF AND ALSO NOTED THAT SOME CATHETERS SEEMED TO BE MORE STICKY THAN OTHERS (LOT: JUFV2649 & LOT: JUFX2803).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13872392 ↗
• MalfunctionJan 14, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY STICKY. PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 13257763 ↗
• MalfunctionNov 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS PULLING OFF THE SKIN WHEN THE CUSTOMER WAS REMOVING THE CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Tears

  MAUDE report 12899738 ↗
• InjuryNov 11, 2021Loss of or Failure to Bond; Inadequacy of Device Shape and/or Size; Loss of or Failure to Bond; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETRACTION WHILE USING THE MALE EXTERNAL CATHETER, WHICH CAUSED A BULB AT THE END OF THE CATHETER THAT LEADS TO THE LEAKING. ALSO, THE PATIENT GOT A RED BUMP ON THE PENIS, ALTHOUGH THERE WAS NO CONFIRMATION WHETHER THE PATIENT THOUGHT THE BUMP WAS CAUSED BY THESE EXTERNALS. PER CUSTOMER VIA PHONE ON (B)(6) 2021, THE CATHETERS WOULD LOSE GRIP AND SLIDE DOWN, AND WOULD STICK TO THEMSELVES AT THE HEAD OF THE PENIS. THE URINE WOULD COLLECT AT THE END OF THE CATHETER INSTEAD OF MOVING INTO THE HOSE OF THE CATHETER BAG. THE PATIENT CHANGED BACK TO THE NATURAL CATHETER. ALSO STATED THAT THE CUSTOMER HAD URINARY TRACT INFECTION (UTI) WITH PRESCRIPTION MEDICATION FROM A PHYSICIAN RELATED TO URINE BUILDING UP AT THE TIP OF THE PENIS. EVEN WHEN ASKED, THE PATIENT WOULD NOT SPECIFY WHICH CATHETER OR BEDSIDE URINARY DRAIN BAG THEY USED. THE UTI WAS ABOUT TWO WEEKS AGO, AND THE LATEST DOCTOR'S APPOINTMENT INDICATED THE PATIENT WAS WELL. THE CUSTOMER SUGGESTED AN AIR RELEASE VALVE BE ADDED TO THE TUBING SO THAT IT COULD BE RELEASED, CAUSING AIR TO PUSH THE URINE TOWARDS THE BAG AND PREVENTING URINE FROM GATHERING AT THE TIP OF THE PENIS. IT WAS REPORTE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Tract Infection

  MAUDE report 12796522 ↗
• InjuryOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETERS WERE CAUSING LEAKAGE AND A POSSIBLE URINARY TRACT INFECTION. UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION. PER FOLLOW UP CALL ON 22OCT2021, CUSTOMER STATED THAT THE CATHETERS WOULD LOOSE GRIP AND SLIP DOWN AND WOULD STICK THEMSELVES AT THE HEAD OF THE PENIS. THE URINE WOULD COLLECT AT THE END OF THE CATHETER INSTEAD OF MOVING INTO THE HOSE OF THE LEG BAG. CUSTOMER HAD CHANGED BACK TO THE NATURAL CATHETER. STATED THAT CUSTOMER HAD EXPERIENCED RASH AND REDNESS WHICH WAS A SELF-MADE TOURNIQUET FROM THE VELCRO STRAPS OF A LEG BAG. CUSTOMER WAS USING THE TOURNIQUET TO PREVENT THE HEAD OF HIS PENIS FROM RETRACTING INTO THE SHAFT. THE RASH WAS A RESULT OF THE VELCRO RUBBING ON HIS SKIN. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD URINARY TRACT INFECTION WITH PRESCRIPTION MEDICATION FROM PHYSICIAN RELATED TO URINE BUILDING UP AT THE TIP OF PENIS. THE URINARY TRACT INFECTION WAS ABOUT TWO WEEKS AGO, AND THE LATEST DOCTOR¿S APPOINTMENT INDICATED THE CUSTOMER WAS WELL. CUSTOMER ALSO SUGGESTED AN AIR RELEASE VALVE BE ADDED TO THE TUBING SO THAT IT COULD BE RELEASED CAUSING AIR TO PUSH THE URINE TOWARDS THE BAG AND PREVENTING U

  Patient problems: Urinary Tract Infection

  MAUDE report 12584714 ↗

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