Porges Coloplast AA6418Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03600040130087), received between Feb 26, 2019 and Oct 4, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS DIFFICULT TO INFLATE AND DEFLATE. DURING THE INFLATION TEST BEFORE DEVICE PLACEMENT, IT WAS DIFFICULT TO INJECT AND REMOVE WATER FROM THE BALLOON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17874035 ↗
• MalfunctionJul 1, 2022Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. THE CATHETER WAS PLACED AFTER INFLATION TEST AND THE BALLOON BURST WITH 15 CC. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887517 ↗
• MalfunctionMay 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE EXPERIENCED A MALFUNCTION DUE TO FLUID LEAKAGE AT THE TRANSITION OF THE SILICONE CATHETER TO THE BLOCKING VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364145 ↗
• MalfunctionMay 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE EXPERIENCED A MALFUNCTION DUE TO FLUID LEAKAGE AT THE TRANSITION OF THE SILICONE CATHETER TO THE BLOCKING VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364066 ↗
• MalfunctionOct 27, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

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

  Patient problems: Pain

  MAUDE report 12704969 ↗
• 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 12661178 ↗
• MalfunctionAug 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER FELL OFF AND A BALLOON BURST WAS DISCOVERED AFTER 1 DAY INDWELLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362504 ↗
• InjuryJul 28, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ACCORDING TO THE AVAILABLE INFORMATION, AFTER INSERTION OF THE CATHETER, THE DISTAL TIP WAS NO LONGER IN PLACE. IT "PROBABLY DETACHED" AND WAS NOT FOUND IN THE PATIENT AFTER CYSTOSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12240825 ↗
• MalfunctionMay 15, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER FELL OFF AFTER 1 DAY INDWELLING. BALLOON BURST WAS FOUND. THE LOT NUMBER OF THE RED VALVE WAS PROVIDED, 6619792.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10062379 ↗
• MalfunctionMar 1, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REFILLING THE BALLOON, THE BALLOON BURST,THE RED VALVE IS LEAKING.

  Patient problems: No Information

  MAUDE report 8382030 ↗
• MalfunctionMar 1, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REFILLING THE BALLOON, THE BALLOON BURST, THE RED VALVE IS LEAKING.

  Patient problems: No Information

  MAUDE report 8382026 ↗
• MalfunctionFeb 26, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REFILLING THE BALLOON, THE BALLOON BURSTS. NO HARM TO USER.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8371537 ↗
• MalfunctionFeb 26, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN REFILLING THE BALLOON, THE BALLOON BURSTS. NO HARM TO USER.

  Patient problems: No Information

  MAUDE report 8371536 ↗