Porges Coloplast AB6022Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03600040143360), received between Oct 31, 2016 and Nov 1, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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-0845-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE AVAILABLE INFORMATION, WHILE INSIDE THE OR A HAIR WAS FOUND WRAPPED IN THE STERILE PACKAGE. THE HAIR IS NOT LOOSE IN THE STERILE PACKAGING BUT IS IN THE PACKAGING OF THE CATHETER ITSELF. THE PACKAGING WAS NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592285 ↗
• MalfunctionSep 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE AVAILABLE INFORMATION, PRESENCE OF HAIR WAS IN THE PACKAGING AND IN CONTACT WITH THE URINARY CATHETER. NO OTHER DEVICES FROM THE SAME BATCH WERE FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301071 ↗
• InjuryMar 18, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT WAS OPERATED FOR PROSTATE RESECTION. THE BALLOON OF THE CATHETER BURST ON RISING. PATIENT WAS CATHETERIZED AGAIN BUT, IN THE MORNING, THE BALLOON OF THE NEW CATHETER BURST. PATIENT EXPERIENCED PAIN AND BLEEDING FROM THE PENIS. PATIENT WAS RE-CATHETERIZED WITH A CRUTCH CATHETER.

  Patient problems: Genital Bleeding; Pain

  MAUDE report 18921687 ↗
• InjuryMar 18, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT WAS OPERATED FOR PROSTATE RESECTION. THE BALLOON OF THE CATHETER BURST ON RISING. PATIENT WAS CATHETERIZED AGAIN BUT, IN THE MORNING, THE BALLOON OF THE NEW CATHETER BURST. PATIENT EXPERIENCED PAIN AND BLEEDING FROM THE PENIS. PATIENT WAS RE-CATHETERIZED WITH A CRUTCH CATHETER.

  Patient problems: Genital Bleeding; Pain

  MAUDE report 18921685 ↗
• InjuryFeb 27, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER TORE AND THE BALLOON BURST. THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AND REQUIRED INTERVENTION. A NEW CATHETER WAS PLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18791952 ↗
• MalfunctionOct 31, 2016Partial Blockage

  ACCORDING TO THE INFORMATION RECEIVED, AS THE CATHETER IS BLOCKED, DROPS FLOW DROPWISE IN THE POUCH. FOR SEVERAL PATIENTS; SAME LOT. ONE PATIENT HAD A CLOTTING BUT THEY NOTICED IT , AND IMMEDIATELY CHANGED THE CATHETER FOR SUPERIOR CH. NO CLINICAL CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6066689 ↗