Porges Coloplast AA6314Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03600040128640), received between Jan 15, 2019 and Oct 30, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 2, 2024Open, Classified

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

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

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT GETS A NEW CATHETER IN AND TWO DAYS LATER THE BALLOON BREAKS. THE PATIENT ENDS UP IN THE EMERGENCY TO GET A NEW CATHETER BECAUSE HE CANNOT VOID HIS URINE.

  Patient problems: Urinary Retention

  MAUDE report 20569179 ↗
• MalfunctionOct 15, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE NURSE INFLATED 10CC OF STERILE WATER FOR TESTING. AFTER THE TESTING, THE NURSE PLACED THE DEVICE AND INFLATED 10CC OF STERILE WATER AGAIN. THE DEVICE SLIPPED OUT FROM THE PATIENT. THE NURSE CHECKED THE DEVICE AND FOUND THAT THE BALLOON BROKE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936842 ↗
• MalfunctionJul 24, 2023Contamination; Contamination

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A HAIR. THERE WAS A HAIR IN THE PACKAGING BEFORE IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375851 ↗
• InjuryMar 28, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT FILLING. THE DEVICE WAS CHECKED AFTER 2 HOURS AND NO URINE HAD COLLECTED IN THE BAG. THE DEVICE WAS NOT ABLE TO BE UNBLOCKED. THE PATIENT HAD A PELVIC ULTRASOUND AND A BLADDER GLOBE WAS FOUND. DURING REPLACEMENT IT WAS FOUND THAT THE DISTAL LUMEN HAD NOT COMPLETELY PUNCTURED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 16627259 ↗
• MalfunctionFeb 16, 2023Separation Problem; Separation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE SEPARATED DURING PLACEMENT. DURING PLACEMENT OF THE DEVICE THE CRUTCH END OF THE DEVICE CAME OFF. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384052 ↗
• MalfunctionFeb 14, 2023Separation Problem; Separation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE SEPARATED DURING PLACEMENT. DURING PLACEMENT OF THE DEVICE THE CRUTCH END OF THE DEVICE CAME OFF. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372048 ↗
• MalfunctionNov 19, 2022Deflation Problem; Deflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO DEFLATION AND INFECTION. THERE WERE NO ISSUES WITH THE INFLATION TEST BEFORE PLACEMENT OF THE DEVICE. AFTER THREE DAYS INDWELLING, THE DEVICE FELL OFF AND THE BALLOON DEFLATED. A LEAK WAS FOUND AT THE TIP SIDE OF THE BALLOON. IT WAS NOTED THE PATIENT HAD A POSSIBLE INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15829810 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE INDWELLING CATHETER BALLOON BURST AFTER 2-3 DAYS WHILE IT WAS INSERTED. THE BALLOON WAS PUMPED 8-10 TIMES. THERE HAS BEEN NO HARM TO THE END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972686 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE INDWELLING CATHETER BALLOON BURST AFTER 2-3 DAYS WHILE IT WAS INSERTED. THE BALLOON WAS PUMPED 8-10 TIMES. THERE HAS BEEN NO HARM TO THE END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972684 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE INDWELLING CATHETER BALLOON BURST AFTER 2-3 DAYS WHILE IT WAS INSERTED. THE BALLOON WAS PUMPED 8-10 TIMES. THERE HAS BEEN NO HARM TO THE END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972683 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE INDWELLING CATHETER BALLOON BURST AFTER 2-3 DAYS WHILE IT WAS INSERTED. THE BALLOON WAS PUMPED 8-10 TIMES. THERE HAS BEEN NO HARM TO THE END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972679 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE INDWELLING CATHETER BALLOON BURST AFTER 2-3 DAYS WHILE IT WAS INSERTED. THE BALLOON WAS PUMPED 8-10 TIMES. THERE HAS BEEN NO HARM TO THE END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972677 ↗
• InjuryJan 15, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON FELL OFF DURING INDWELLING DUE TO BALLOON BURST, THE PHYSICIAN CONFIRMED NO RESIDUE OR PARTICLE REMAINS IN PATIENT'S BLADDER, REPLACED WITH NEW CATHETER IMMEDIATELY. NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Information

  MAUDE report 8248323 ↗