Porges Coloplast AA6C18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03600040131992), received between Dec 18, 2018 and Mar 13, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER TIP CAME LOOSE PRIOR TO CATHETERIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600525 ↗
• MalfunctionJun 15, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION A CATHETER WAS INSERTED AND SHORTLY AFTER, THE CATHETER CAME OUT BECAUSE THE BALLOON WAS PIERCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543958 ↗
• InjuryDec 17, 2021Difficult to Remove; Material Too Rigid or Stiff; Failure to Deflate; Difficult to Remove; Material Too Rigid or Stiff; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, THE NURSES WERE UNABLE TO DEFLATE THE BALLOON AND HAD TO SEND THE PATIENT TO THE HOSPITAL "A FEW TIMES" TO GET THE CATHETER REMOVED. THE BALLOON WAS HARD AND IT APPEARED THAT THE SOLUTION INSIDE HAD CRYSTALIZED. IT WAS UNCLEAR WHAT THE NURSES USED TO INFLATE IT, BUT THE DOCTOR WHO REMOVED THE CATHETER THOUGHT MAYBE NORMAL SALINE HAD BEEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025530 ↗
• InjuryDec 18, 2018Burst Container or Vessel; Burst Container or Vessel

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

  Patient problems: No Information

  MAUDE report 8174798 ↗