Porges Coloplast AA6108Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03600040126974), received between Apr 7, 2016 and Mar 20, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Nonstandard Device

  ACCORDING TO THE AVAILABLE INFORMATION A MANUFACTURING DEFECT HAS BEEN DETECTED IN COLOPLAST PEDIATRIC URINARY CATHETERS BEFORE USE. THE GUIDE WIRE PROTRUDES FROM THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654810 ↗
• MalfunctionApr 25, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION, THE NURSE EXPERIENCED RESISTANCE AND DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT. UPON REMOVAL IT WAS DISCOVERED THAT THE BALLOON HAD FOLDED BACK ON ITSELF. THIS WAS AN ISOLATED INCIDENT, RESULTING IN INCREASED PAIN FOR THE PATIENT.

  Patient problems: Pain

  MAUDE report 21910667 ↗
• MalfunctionApr 22, 2025Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON OF A PEDIATRIC CATHETER EXPLODED (BURST) AFTER FILLING WITH 2 ML OF LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885317 ↗
• InjuryJan 23, 2025Delivered as Unsterile Product; Insufficient Device Problem Information; Delivered as Unsterile Product; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, A PARENT CALLED TO REPORT HER CHILD HAD DEVELOPED A URINARY TRACT INFECTION THAT REQUIRED MEDICAL INTERVENTION AFTER USING ITEM AA6108.

  Patient problems: Urinary Tract Infection

  MAUDE report 21223593 ↗
• MalfunctionMar 28, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST DURING USE. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994842 ↗
• MalfunctionJan 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  ACCORDING TO THE AVAILABLE INFORMATION AN EYELASH WAS WELDED INTO THE INNER STERILE PACKAGING. NO DEFICITS FOR PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453986 ↗
• MalfunctionAug 3, 2022Deflation Problem; Difficult to Fold, Unfold or Collapse; Difficult to Remove; Deflation Problem; Difficult to Fold, Unfold or Collapse; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION, IN A NEONATAL INTENSIVE CARE UNIT, A NURSE WANTED TO REMOVE THE URINARY CATHETER FROM A NEW BORN. AFTER DEFLATION OF THE BALLOON, THE NURSE FELT RESISTANCE DURING EXTRACTION OF THE LAST 0.5 CENTIMETERS; THE CATHETER SEEMED IMPOSSIBLE TO REMOVE. THE CATHETER WAS INTRODUCED AGAIN, LUBRICATED, THEN EXTRACTED WITH SUCCESS, BUT WITH FORCE. THE CATHETER WAS TESTED ONCE AFTER REMOVING IT; THE BALLOON CORRECTLY INFLATED BUT DID NOT FOLD CORRECTLY DURING DEFLATION, TAKING THE ASPECT OF A "RING". THERE WAS NO CLINICAL CONSEQUENCE FOR THE NEWBORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156306 ↗
• InjuryJan 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE AVAILABLE INFORMATION, THE SURGEON PLACED A BLADDER STENT WITHOUT ANY NOTICEABLE ISSUES DURING AN APPENDECTOMY OF A YOUNG PATIENT. POST OPERATIVELY, THE STENT WAS LEFT IN PLACE. FIFTEEN MINUTES AFTER THE PATIENT ARRIVED IN THE RECOVERY ROOM, THE SURGEON WAS CALLED BACK BECAUSE THE STENT WAS NO LONGER IN PLACE. THE STENT WAS "CUT IN HALF" AND THE DISTAL END REMAINED IN THE BLADDER. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND A CYSTOSCOPY WAS PERFORMED TO REMOVE THE DISTAL END. THERE WERE NO SUBSEQUENT CONSEQUENCES. THE BALLOON HAD NOT BEEN INFLATED PRIOR TO INSTALLATION. NO SHARP OBJECTS HAD BEEN USED. IT WAS REPORTED THAT PROBING MANDREL IN PLACE, THERE WAS GREATER RESISTANCE THAN USUAL WHEN WITHDRAWING THE MANDREL. IT WAS PROBABLE SHEAR INJURY AT THIS TIME; SPONTANEOUS RUPTURE OF THE PROBE OCCURRED APPROXIMATELY 30 MINUTES LATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11120494 ↗
• MalfunctionJul 3, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, CATHETER LAID IN PATIENT´S DIAPERS - BALLOON LOOKS DAMAGED. IT IS UNCLEAR IF THE TIP IS DAMAGED OR MISSING.

  Patient problems: No Information

  MAUDE report 8761190 ↗
• InjuryMay 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, UNBLOCKING, ASPIRATED WITH 2 ML (MORE WAS NOT POSSIBLE, 3X CONTROLLED) THEN REMOVED, THIS WAS EASILY POSSIBLE, THEN A SHORT "ZAPPING" COULD BE HEARD, THE CATHETER WAS TORN IN THE PATIENT AND HAD TO BE REMOVED SURGICALLY.

  Patient problems: No Information

  MAUDE report 8655137 ↗
• MalfunctionJun 30, 2017Deflation Problem; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION, AT THE TIME OF WITHDRAWAL OF THE CATHETER (48 HOURS AFTER HAVING PLACED IT IN THE PATIENTS' BODY), THE DEFLATION OF BALLOON WAS PERFORMED BUT THE CATHETER REMAINED BLOCKED IN THE URETHRAL MEATUS. ACCORDING TO THE NURSE, IT SEEMED LIKE THE BALLOON WAS NOT ENOUGH DEFLATED. THE CATHETER HAD TO BE PULLED TO BE WITHDRAWN, AN INFLAMMATION OF THE PENIS WAS REPORTED. DID THEY TRIED TO INFLATE/DEFLATE THE BALLOON ? - YES SEVERAL TIMES. THE BALLOON WAS EMPTY ? YES, IT WAS THICK BUT NO MORE FLUID IN THE BALLOON.

  Patient problems: Inflammation

  MAUDE report 6681622 ↗
• MalfunctionApr 7, 2016Hole In Material; Device Slipped

  ACCORDING TO THE AVAILABLE INFORMATION, CATHETER HAS BEEN INSERTED TO A PEDIATRIC PATIENT IN EMERGENCY UNIT BECAUSE OF URINARY RETENTION. PATIENT WAS THEN TRANSFERRED TO PEDIATRIC WARD, WHERE THE CATHETER HAD COME OUT BY ITSELF THE NEXT MORNING. CATHETER'S BALLOON WAS TESTED AND IT WAS FOUND OUT THAT THE FLUID DOESN'T STAY INSIDE THE BALLOON, AND THAT THERE WAS A HOLE ON THE CATHETER'S BALLOON FLUID CANAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5555815 ↗