Porges Coloplast AA6114Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 03600040127360), received between Oct 27, 2015 and Jun 3, 2025 — classified as 1 death, 26 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 2, 2024Class IIOpen, Classified

   A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

   Z-0844-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE BLADDER CATHETER, THE BALLOON WAS UNABLE TO BE DEFLATED.

  Patient problems: Insufficient Information

  MAUDE report 22132207 ↗
• MalfunctionApr 21, 2025Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST TWO DAYS AFTER THE CATHETER WAS INSERTED, AND THE CATHETER CAME OUT. THE PATIENT SUFFERED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875309 ↗
• DeathFeb 25, 2025Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem; Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PASSED AWAY IN (B)(6) 2024 DUE TO SEPSIS. THE PATIENT'S FAMILY CONCLUDED THAT THE USE OF THE FOLYSIL CATHETER HAD A DIRECT CORRELATION WITH THE PATIENT'S DEATH.

  Patient problems: Sepsis

  MAUDE report 21458068 ↗
• InjuryFeb 11, 2025Delivered as Unsterile Product; Insufficient Device Problem Information; Delivered as Unsterile Product; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAS BEEN HAVING ONGOING ISSUES WITH BLADDER INFECTIONS WITH HER CATHETER FROM (B)(6) 2023 - THE SPRING OF 2024. THE PATIENT HAS BEEN CATHING AND USING CATHETERS FOR 26 YEARS WITHOUT INCIDENT BUT THEIR INFECTIONS HAVE BECOME SO CONSTANT AND PERSISTENT THAT THEY HAVE HIT ANTIBIOTIC RESISTANCE AFTER NUMEROUS COURSES OF ANTIBIOTICS. THE PATIENT HAS UNDERGONE CT SCANS AND RENAL SCANS THAT HAVE ALL BEEN NORMAL. THE PATIENT WILL BE HAVING A CYSTOSCOPY TO VERIFY THAT NOTHING IS INSIDE THEIR BLADDER CAUSING THESE RECURRENT INFECTIONS. PATIENT IS CURRENTLY DOING ANTIBIOTICS FLUSH DIRECTLY INTO THEIR BLADDER WITH A CATHETER DAILY TO PREVENT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 21357135 ↗
• InjuryJan 24, 2025Tear, Rip or Hole in Device Packaging; Insufficient Device Problem Information; Tear, Rip or Hole in Device Packaging; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, INCREASED HOSPITALIZATIONS FOR UTIS IN (B)(6)..

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 21232093 ↗
• MalfunctionJan 6, 2025Separation Problem; Separation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER TIP CAME LOOSE WHEN OPENING THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079244 ↗
• InjuryDec 13, 2024Material Separation; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, DURING THE PATIENT¿S MOVEMENT IN THE BED, THE BLADDER CATHETER BREAKS (IT IS NOT KNOWN IF IT OCCURRED BY PULLING). THE TIP AND BALLOON REMAINED IN THE BLADDER. THE TIP AND BALLOON WERE REMOVED BY ENDOSCOPIC WITH CYSTOSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20925934 ↗
• InjuryOct 15, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, THE EVENT OCCURRED DURING ROBOTIC-ASSISTED GYNECOLOGICAL SURGERY. A URINARY CATHETER IS ROUTINELY INSERTED AT THE BEGINNING OF THE PROCEDURE TO EMPTY THE BLADDER AND LIMIT THE RISK OF INJURY. THE STERILE CATHETER GIVEN DIRECTLY TO A CAREGIVER, WHO MOUNTS IT ON THE BAG WITHOUT CHECKING THE BALLOON, AND THEN PLACES THE DEVICE. THERE WAS A NEED TO PERFORM A BLADDER LEAK TEST, AND THE BALLOON APPEARED PUNCTURED. THE CATHETER DOES NOT HOLD AND WHEN IT IS REMOVED, IT IS CLEAR THAT 1CM OF THE CATHETER TIP IS MISSING. CLINICAL CONSEQUENCES: LONGER OPERATING TIME, AS CYSTOSCOPY WAS REQUIRED, FOLLOWED BY A VAGINAL APPROACH TO CHECK FOR ITS PRESENCE. PIECE NOT FOUND EITHER IN THE PATIENT OR IN THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457552 ↗
• InjuryOct 15, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE EVENT OCCURRED DURING ROBOTIC-ASSISTED GYNECOLOGICAL SURGERY. A URINARY CATHETER IS ROUTINELY INSERTED AT THE BEGINNING OF THE PROCEDURE TO EMPTY THE BLADDER AND LIMIT THE RISK OF INJURY. THE STERILE CATHETER GIVEN DIRECTLY TO A CAREGIVER, WHO MOUNTS IT ON THE BAG WITHOUT CHECKING THE BALLOON, AND THEN PLACES THE DEVICE. THERE WAS A NEED TO PERFORM A BLADDER LEAK TEST, AND THE BALLOON APPEARS PUNCTURED. THE CATHETER DOES NOT HOLD AND WHEN IT IS REMOVED, IT IS CLEAR THAT 1CM OF THE CATHETER TIP IS MISSING. CLINICAL CONSEQUENCES: LONGER OPERATING TIME, AS CYSTOSCOPY WAS REQUIRED, FOLLOWED BY A VAGINAL APPROACH TO CHECK FOR ITS PRESENCE. PIECE NOT FOUND EITHER IN THE PATIENT OR IN THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456738 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, UPON OPENING THE URINARY CATHETER. THE TIP OF THE CATHETER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407398 ↗
• MalfunctionJul 18, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ACCORDING TO THE AVAILABLE INFORMATION, DURING PREPARATION THE NURSE NOTICED THE END OF THE MD WAS DETACHED FROM THE REST OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771457 ↗
• MalfunctionJul 8, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE URINARY CATHETER WAS INSERTED AT THE BEGINNING OF THE PROCEDURE WITHOUT ANY PROBLEMS. AT THE END OF THE OPERATION THE CATHETER FALLS OUT AND THE BALLOON WAS FOUND RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691842 ↗
• InjuryFeb 12, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO ADDITIONAL AVAILABLE INFORMATION, THE INDICATION FOR CATHETERIZATION WAS SEVERE DEMENTIA AND MALNUTRITION. THE BALLOON WAS TESTED PRIOR TO USE WITH NO ANOMALY AND OPTILUBE LUBRICANT WAS USED ON CATHETER. THE VOLUME OF INFLATION FLUID WAS 20ML AND STERILE WATER WAS USED. NO SYMPTOMS DEVELOPED WITHIN THE 24 HOURS FOLLOWING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689313 ↗
• MalfunctionJan 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE AVAILABLE INFORMATION WHEN THE NURSE OPENED THE PRIMARY PACKAGING ON THE CLEAN AREA, SHE NOTICED A FOREIGN MATERIAL LIKE HAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466284 ↗
• MalfunctionDec 19, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION PRIOR TO INSERTION AND DURING TESTING, BALLOON DEFLATE WAS IMPOSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358323 ↗
• InjuryDec 7, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ACCORDING TO THE AVAILABLE INFORMATION SEVERAL PENIS SORES HAVE BEEN OBSERVED ON PATIENTS. APPEARANCE APPROXIMATELY 15 DAYS AFTER PLACEMENT OF THE CATHETER. IT IS EXTREMELY PAINFUL FOR THE PATIENTS. THE CATHETER IS TOO RIGID AND PROBLEMS ARISE WHEN THE CATHETER REMAINS IN PLACE FOR A LONG TIME.

  Patient problems: Necrosis; Pain

  MAUDE report 18287461 ↗
• InjuryDec 7, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ACCORDING TO THE AVAILABLE INFORMATION SEVERAL PENIS SORES HAVE BEEN OBSERVED ON PATIENTS. APPEARANCE APPROXIMATELY 15 DAYS AFTER PLACEMENT OF THE CATHETER. IT IS EXTREMELY PAINFUL FOR THE PATIENTS. THE CATHETER IS TOO RIGID AND PROBLEMS ARISE WHEN THE CATHETER REMAINS IN PLACE FOR A LONG TIME.

  Patient problems: Necrosis; Pain

  MAUDE report 18287404 ↗
• InjuryDec 7, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ACCORDING TO THE AVAILABLE INFORMATION SEVERAL PENIS SORES HAVE BEEN OBSERVED ON PATIENTS. APPEARANCE APPROXIMATELY 15 DAYS AFTER PLACEMENT OF THE CATHETER. IT IS EXTREMELY PAINFUL FOR THE PATIENTS. THE CATHETER IS TOO RIGID AND PROBLEMS ARISE WHEN THE CATHETER REMAINS IN PLACE FOR A LONG TIME.

  Patient problems: Necrosis; Pain

  MAUDE report 18287206 ↗
• InjuryNov 16, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT PULLED OUT AN INDWELLING CATHETER, AND WAS FOUND TO BE MISSING THE BALLOON, WHICH HAD BEEN CUT OFF. THE BALLOON WAS NOT FOUND IN THE ROOM OR THE PATIENT AFTER ENDOSCOPY FOR CYSTOSCOPY WAS PERFORMED. THE PATIENT WAS RE-CATHETERIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149935 ↗
• MalfunctionOct 21, 2023Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. WHEN THE STERILE WATER WAS INJECTED TO INFLATE THE BALLOON, IT RUPTURED. THE PATIENT HAD TO BE CATHETERIZED AGAIN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981976 ↗
• MalfunctionSep 30, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT ABLE TO DEFLATE. THE DEVICE WAS PLACED, THE BALLOON WAS TESTED FOR INFLATION. IT COULD BE INFLATED BUT COULD NOT BE DEFLATED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849117 ↗
• MalfunctionSep 21, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD DIFFICULT DEFLATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17795825 ↗
• MalfunctionJul 18, 2023Fracture; Difficult to Open or Remove Packaging Material; Fracture; Difficult to Open or Remove Packaging Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BREAK. THE TIP BROKE OFF WHEN THE PACKAGE WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340087 ↗
• MalfunctionJul 18, 2023Fracture; Difficult to Open or Remove Packaging Material; Fracture; Difficult to Open or Remove Packaging Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BREAK. THE TIP BROKE OFF WHEN THE PACKAGE WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340072 ↗
• MalfunctionJul 18, 2023Fracture; Difficult to Open or Remove Packaging Material; Fracture; Difficult to Open or Remove Packaging Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BREAK. THE TIP BROKE OFF WHEN THE PACKAGE WAS OPENED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340067 ↗