Porges Coloplast AA6312Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03600040128510), received between Aug 12, 2016 and Jul 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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-0844-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER TEARS APART WHEN THE PACKAGE IS OPENED. THE CATHETER WAS NOT USED, AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252317 ↗
• InjuryMay 1, 2017Deflation Problem

  THEY WERE CONFRONTED WITH THE IMPOSSIBILITY OF DEFLATING THE BALLOONS FOLEY. FOR ONE OF THE PATIENT THE CONSEQUENCES WERE IMPORTANT: INCREASE OF THE DURATION OF HOSPITALIZATION, INFECTION. "THE PRODUCT INFORMATION FOR THE DEVICE WAS NOT AVAILABLE AT THE TIME OF THE COMPLAINT. THEREFORE, THE ITEM NUMBER ABOVE WAS USED ONLY TO RECORD THE PRODUCT TYPE, BUT MAY NOT REFLECT THE CORRECT SIZE. ADDITIONAL INFORMATION WILL BE ADDED, IF IT BECOMES AVAILABLE".

  Patient problems: Unspecified Infection

  MAUDE report 6534923 ↗
• InjuryAug 12, 2016Break; Improper or Incorrect Procedure or Method

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER HAS BEEN PULLED OFF BY FORCE BY THE PATIENT, HOW THE CATHETER IS NOT MEANT TO BE USED. CATHETER HAS BEEN INSERTED INTO A STROKE PATIENT (PATIENT IS RESTLESS , NO SENSATION OF ILLNESS). LATER, PATIENT HAS PULLED OFF THE CATHETER. CATHETER HAS BROKEN IN HALF AND APPROXIMATELY HALF OF THE CATHETER HAS STAYED INSIDE THE PATIENT. PATIENT HAS BEEN SENT TO A HOSPITAL FOR AN OPERATION TO TAKE THE CATHETER OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5873247 ↗