Porges Coloplast AB6222Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03600040144084), received between Sep 4, 2020 and Mar 12, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 2, 2024Open, Classified

   A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

   Z-0845-2025 · Root cause: Packaging · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE AVAILABLE INFORMATION A FOREIGN HAIR LIKE PARTICLE IS INSIDE THE STERILE PACKAGE. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890086 ↗
• MalfunctionJul 28, 2023Microbial Contamination of Device; Microbial Contamination of Device

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN OPENING THE PRODUCT PACKAGING, THE NURSE DISCOVERED THE PRESENCE OF A HAIR INSIDE THE POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416085 ↗
• MalfunctionFeb 11, 2022Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WAS RETURNING FROM THE OPERATION ROOM WITH AN IRRIGATION CATHETER. THE BALLOON BURST AND THE CATHETER DID NOT HOLD ANYMORE AND FELL OUT OF THE URINARY MEATUS. A NEW CATHETER WAS PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517122 ↗
• MalfunctionFeb 11, 2022Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WAS RETURNING FROM THE OPERATION ROOM WITH AN IRRIGATION CATHETER. THE BALLOON BURST AND THE CATHETER DID NOT HOLD ANYMORE AND FELL OUT OF THE URINARY MEATUS. A NEW CATHETER WAS PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517096 ↗
• InjuryFeb 8, 2022Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WAS RETURNING FROM THE OPERATION ROOM WITH AN IRRIGATION CATHETER. THE BALLOON BURST AND THE CATHETER DID NOT HOLD ANYMORE AND FELL OUT OF THE URINARY MEATUS. A NEW CATHETER WAS PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480717 ↗
• MalfunctionOct 19, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON ON THE CATHETER DOES NOT SEAL. THE BALLOON DETACHES FROM THE CATHETER (BURSTS). THE PHYSICIAN HAD ALWAYS BLOCKED WITH 80 ML THE LAST FEW YEARS, AND NOTHING HAD EVER HAPPENED. AFTER THE INCIDENT WITH THE BURST BALLOONS, BLOCKING WAS DONE WITH 30-50 ML, BUT THE SAME PROBLEM OCCURRED. IT WAS NOTED THIS HAPPENED WITH SEVERAL LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656685 ↗
• InjuryOct 18, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON ON THE CATHETER DOES NOT SEAL. THE BALLOON DETACHES FROM THE CATHETER (BURSTS). THE BALLOON REMNANTS WERE REMOVED UNDER A CYSTOSCOPE; THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE PHYSICIAN HAD ALWAYS BLOCKED WITH 80 ML THE LAST FEW YEARS, AND NOTHING HAD EVER HAPPENED. AFTER THE INCIDENT WITH THE BURST BALLOONS, BLOCKING WAS DONE WITH 30-50 ML, BUT THE SAME PROBLEM OCCURRED. IT WAS NOTED THIS HAPPENED WITH SEVERAL LOT NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648107 ↗
• MalfunctionSep 4, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURSTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497269 ↗