Porges Coloplast AA6316Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03600040128770), received between Mar 1, 2017 and Mar 24, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR SUSTAINED A SMALL PUNCTURE WOUND TO THE RIGHT INDEX FINGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676992 ↗
• MalfunctionJul 24, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, DURING PATIENT INDWELLING, THE BALLOON BURST AND FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822786 ↗
• MalfunctionJul 5, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION WHEN THE NURSE UNPACKED THE CATHETER, THE DISTAL END SEPARATED FROM THE BODY OF THE CATHETER. A NEW CATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681376 ↗
• MalfunctionApr 24, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION UPON TESTING, THE BALLOON WAS FILLED WITH WATER AND INFLATED BUT WAS UNABLE TO REMOVE THE WATER AND DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177415 ↗
• MalfunctionJan 4, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, PRIOR TO INSERTION, THE BALLOON TEST WAS DONE WITH 15ML OF STERILE WATER WITHOUT DIFFICULTY. THE PLACEMENT OF THE CATHETER DID NOT PRESENT ANY PROBLEM WITH A GOOD RETURN OF URINE. FOLLOWING INFLATION OF THE BALLOON WITH 15ML OF WATER THE URINE BECAME PINK THEN HEMATURIC WITH BLOOD CLOTS. WHEN REMOVING THE CATHETER THE NURSE OBSERVED THE BALLON BURST. A NEW CATHETER WAS PLACED WITHOUT PAIN SUCCESSFULLY.

  Patient problems: Hematuria

  MAUDE report 18445224 ↗
• MalfunctionMar 21, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REMOVAL DUE TO A BALLOON BURST. THE ADMINISTRATIVE TECHNICIAN AT THE MEDICAL FACILITY SAID THE DEVICE BALLOON BURST AFTER PLACEMENT. IT HAPPENED IN LESS THAN A WEEK OF USING THE DEVICE BY THE USER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585762 ↗
• MalfunctionFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON BURST. THE BALLOON BURST WHEN INFLATED TO 15 ML AS ADVISED BUT PROVIDER FOUND THAT THE BALLOON WAS ONLY ABLE TO BE INFLATED TO 7 ML WHEN TRIED ON OTHER DEVICES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292124 ↗
• MalfunctionFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON BURST. THE BALLOON BURST WHEN INFLATED TO 15 ML AS ADVISED BUT PROVIDER FOUND THAT THE BALLOON WAS ONLY ABLE TO BE INFLATED TO 7 ML WHEN TRIED ON OTHER DEVICES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292062 ↗
• MalfunctionFeb 2, 2023Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON BURST. THE BALLOON BURST WHEN INFLATED TO 15 ML AS ADVISED BUT PROVIDER FOUND THAT THE BALLOON WAS ONLY ABLE TO BE INFLATED TO 7 ML WHEN TRIED ON OTHER DEVICES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282619 ↗
• MalfunctionDec 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO CONTAMINATION. THE DEVICE HAD FIXED DIRT ON THE BENT END AND LOOSE DIRT WITHIN THE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070082 ↗
• MalfunctionDec 17, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT LOST HER CATHETER BECAUSE THE BALLOON BURST. A NEW CATHETER WAS PLACED WITHOUT DIFFICULTY, THERE WAS NO PAIN FOR THE PATIENT AND THE PATIENT HAD A GOOD GENERAL STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027767 ↗
• MalfunctionFeb 18, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE BALLOON IS INFLATED AFTER BEING PUT IN PLACE, THE BALLOON BURSTS. THIS OCCURRED FOUR TIMES WITH CATHETERS FROM THE SAME LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11342541 ↗
• InjuryJan 5, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED FOUR CATHETER BURSTS. THE PATIENT HAD BEEN SELF-INSERTING FOLEY CATHETERS FOR FIVE YEARS. HE UTILIZED A PREFILLED 15CC SYRING FOR INFLATION, AND A STATLOCK TO HOLD THE CATHETER IN PLACE. THE CATHETERS BURST AFTER LESS THAN 1 DAY IN PLACE. THE PATIENT STATED HE HAD NOT VISITED THE DOCTOR OR EMERGENCY ROOM FOR ANY TREATMENT, BUT ON ALL FOUR OCCASIONS, IT APPEARED ALL THE PIECES CAME OUT. THE PATIENT NOTED HE HAD EXPERIENCED BLADDER INFECTIONS AS A RESULT OF THE BURSTS BECAUSE THE STERILE WATER FROM THE BALLOON ENTERED HIS BLADDER. THE PATIENT WAS NOT EXPERIENCING ANY ADDITIONAL COMPLICATIONS AT THE TIME THIS INFORMATION WAS REPORTED. ALL FOUR CATHETERS THAT BURST HAD THE SAME LOT NUMBER.

  Patient problems: Urinary Tract Infection

  MAUDE report 11117988 ↗
• MalfunctionJun 26, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WITHIN A FEW HOURS INDWELLING, THE CATHETER FELL OFF. BALLOON BURST WAS FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10202398 ↗
• MalfunctionDec 7, 2018Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST. THERE WERE NO CLINICAL CONSEQUENCE.

  Patient problems: No Information

  MAUDE report 8143614 ↗
• MalfunctionMar 1, 2017Material Rupture

  END USER BEGAN EXPERIENCE A HIGH LEVEL OF BLADDER PAIN. HE SOUGHT TREATMENT AT THE ER. THE CAUSE OF THE PAIN WAS RUPTURE OF THE BALLOON. THE IC IS REPLACED EVERY 4 WEEKS AT HIS UROLOGISTS' OFFICE. THE IC WAS DUE TO BE REPLACED ON TUESDAY (B)(6) 2017. UPON EXAMINATION AT THE ER, THE NURSE ATTEMPTED TO REDUCE THE BALLOON, BUT SINCE IT RUPTURED, THERE WAS NOTHING TO REDUCE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. THE ER DEPARTMENT CONDUCTED "A SCAN" (ULTRASOUND?) AND NO EVIDENCE OF MATERIAL WAS NOTED. PATIENT WAS DISCHARGED AFTER 4 HOURS.

  Patient problems: Pain

  MAUDE report 6367968 ↗