Porges Coloplast AA6416Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03600040129975), received between Mar 5, 2018 and Jan 8, 2024 — classified as 1 injury, 8 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-0844-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST.

  Patient problems: Insufficient Information

  MAUDE report 18465210 ↗
• MalfunctionAug 24, 2023Insufficient Device Problem Information; Failure to Deflate; Insufficient Device Problem Information; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, WATER COULD NOT BE REMOVED FROM THE BALLOON OF THIS DEVICE. DURING THE INFLATION TEST, THE WATER COULD NOT BE REMOVED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17615385 ↗
• MalfunctionJul 31, 2023Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BURST. THE BALLOON BURST WHILE TESTING BEFORE USE. NO OTHER PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431296 ↗
• MalfunctionMar 30, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO DEFLATE. AFTER 2 WEEKS INDWELLING, THE BALLOON COULD NOT BE DEFLATED COMPLETELY. THE DOCTOR PULLED OUT THE DEVICE AS IT WAS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645955 ↗
• MalfunctionOct 3, 2022Deflation Problem; Deflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NO LONGER ABLE TO BE USED DUE TO DEFLATION. A FEW DAYS AFTER PLACEMENT, THE DEVICE FELL OUT AND THE BALLOON DEFLATED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532305 ↗
• MalfunctionSep 28, 2022Deflation Problem; Deflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON DEFLATION. DURING PATIENT STAY, THE DEVICE FELL OUT AND THE DEFLATED BALLOON WAS FOUND. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498799 ↗
• MalfunctionOct 19, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DID NOT COMPLETELY DEFLATE DURING WITHDRAWAL. IT CREATED A "PLEATED BLISTERING" WHICH INCREASED THE DIAMETER AND "ADD RELIEFS" MAKING THE WITHDRAWAL DIFFICULT AND PAINFUL FOR THE PATIENT.

  Patient problems: Pain

  MAUDE report 12661040 ↗
• MalfunctionJul 30, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, CATHETER FELL OFF WITHIN 2 WEEKS INDWELLING. BALLOON BURST. NO CLINICAL CONSEQUENCE FOR THE PATIENT. NEW FOLYSIL CATHETER WAS OPENED AND USED ALTERNATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843081 ↗
• InjuryMar 5, 2018Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, BALLOON BURSTS AFTER SEVERAL HOURS INDWELLING. THE PATIENT HAD BLADDER STONES. DR. CONFIRMED NO PARTICLES REMAINED IN BLADDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313685 ↗