Porges Coloplast AB6A22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040145968), received between Dec 18, 2019 and Aug 31, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO THE AVAILABLE INFORMATION THE USER FOUND A HAIR INSIDE THE TUBING OF THE CATHETER. NO ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661689 ↗
• InjuryDec 18, 2019Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION CATHETER BALLOON FAILED TO DEFLATE ON (B)(6) 2019. WHEN ATTEMPTS WERE MADE NO WATER CAME OUT. AN ULTRASOUND SCAN CONFIRMED CATHETER BALLOON INTACT AND FULL DESPITE MEASURES TO DEFLATE. THE PATIENT WAS TAKEN BACK TO THEATRE AND HAD CATHETER REMOVED UNDER GENERAL ANAESTHETIC. OPERATION NOTE STATES THAT THE BALLOON WAS PUNCTURED WITH SCORE AND ON INSPECTION INTACT APART FROM SPLIT WHERE SCOPE ENTERED. NO PATIENT INJURY OR HARM WAS NOTED.

  Patient problems: No Information

  MAUDE report 9490770 ↗