Porges Coloplast AA6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03600040127100), received between May 23, 2016 and Dec 22, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE AVAILABLE INFORMATION DIFFICULTY REMOVING THE MANDREL, IT SEEMED STUCK TO THE PROBE. THE NURSE HAD TO FORCE IT OUT, WHICH CAUSED PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 23863226 ↗
• MalfunctionNov 26, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  ACCORDING TO THE AVAILABLE INFORMATION WHILE INSERTING A URINARY CATHETER INTO A CHILD FOR A CYSTOGRAPHY, DIFFICULTY WAS ENCOUNTERED IN PASSING THE BLADDER SPHINCTER, AS THE CHILD WAS PARTICULARLY UNDER TENSION. THE CATHETER BALLOON, WHICH HAD BEEN TESTED PRIOR TO INSERTION AND FOUND TO BE INTACT, WAS INFLATED WITHOUT ANY APPARENT DIFFICULTY. WHEN THE MANDREL WAS REMOVED, UNUSUAL RESISTANCE WAS OBSERVED, ASSOCIATED WITH TORSION OF THE CATHETER TIP. THE CATHETER WAS REMOVED BY EXERCISING ABOVE-NORMAL FORCE. DURING THE RADIOLOGICAL EXAMINATION, THE RADIOLOGIST NOTED THAT THE CATHETER WAS NOT IN PLACE AND THAT THE BALLOON WAS INFLATED AT THE LEVEL OF THE URETHRA. THE CATHETER WAS THEN REMOVED IN THE RADIOLOGY DEPARTMENT. THE INCIDENT LED TO THE POSTPONEMENT OF THE PATIENT'S EXAMINATION.

  Patient problems: Insufficient Information

  MAUDE report 23658326 ↗
• MalfunctionJun 5, 2025Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN 3 ML OF FIXING SOLUTION WAS INJECTED DURING CATHETER PLACEMENT, THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154257 ↗
• MalfunctionAug 12, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, A BLADDER CATHETER WAS INSERTED AND WHEN THE BALLOON WAS INFLATED THE BALLOON WAS OBSERVED TO RUPTURE. THE DEVICE WAS CHANGED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961932 ↗
• MalfunctionMay 23, 2024No Flow; No Flow

  ACCORDING TO THE AVAILABLE INFORMATION A BLADDER CATHETER WAS PLACED BUT THERE WAS AN ABSENCE OF URINE DURING SURGERY. PATIENT WAS RE-CATHETERIZED WITH A NEW CATHETER.

  Patient problems: Urinary Retention

  MAUDE report 19382941 ↗
• MalfunctionNov 8, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE IS PACKED SO THAT THE STYLET IS ALREADY INSIDE THE PRODUCT. THE STYLET SHOULD NOT COME OUT FROM THE OPENING OF THE TIP. IF THIS PRODUCT WAS USED IT MIGHT HAVE HARMED THE PEDIATRIC PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092976 ↗
• InjuryJun 8, 2023Off-Label Use; Positioning Problem; Physical Resistance/Sticking; Off-Label Use; Positioning Problem; Physical Resistance/Sticking

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REMOVAL DUE TO DIFFICULT PLACEMENT. THE PATIENT HAS THE DEVICE PLACED BY HIS MOTHER. INSERTION OF THE DEVICE IS DIFFICULT AND THE DEVICE CANNOT BE INSERTED WHEN THE GUIDE WIRE IS OUT FROM THE DEVICE BEFORE INSERTION. THE MOTHER REPORTS SHE COULD NOT GET THE DEVICE IN PLACE AND HAD TO TAKE IT OUT. THE GUIDE WIRE HAS BROKEN THE WALL OF THE URETHRA, BECAUSE SOME TIMES THERE HAS BEEN BLOOD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17094885 ↗
• MalfunctionMay 22, 2023Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A MALFUNCTION. THE MANDRIN STEPPED OUT TO THE SIDE AND COULD CAUSE AN INJURY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16980270 ↗
• MalfunctionAug 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE CHILDREN'S CATHETER CAUSED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15193216 ↗
• MalfunctionDec 16, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THREE BALLOONS BURST IN THE PEDIATRIC PATIENT¿S BLADDER WHEN THE BALLOON WAS BLOCKED WITH 6 ML. THE MOTHER BLOCKS THE BALLOON AND HAD USED THE PRODUCT DAILY FOR SEVERAL MONTHS. SHE STATED THE BALLOON CAN BE BLOCKED WITH MAXIMUM 15 ML, BUT IT WAS NOTED SHE HAD NOT READ THE INSTRUCTIONS FOR USE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019473 ↗
• MalfunctionDec 16, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THREE BALLOONS BURST IN THE PEDIATRIC PATIENT¿S BLADDER WHEN THE BALLOON WAS BLOCKED WITH 6 ML. THE MOTHER BLOCKS THE BALLOON AND HAD USED THE PRODUCT DAILY FOR SEVERAL MONTHS. SHE STATED THE BALLOON CAN BE BLOCKED WITH MAXIMUM 15 ML, BUT IT WAS NOTED SHE HAD NOT READ THE INSTRUCTIONS FOR USE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019469 ↗
• MalfunctionDec 16, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THREE BALLOONS BURST IN THE PEDIATRIC PATIENT¿S BLADDER WHEN THE BALLOON WAS BLOCKED WITH 6 ML. THE MOTHER BLOCKS THE BALLOON AND HAD USED THE PRODUCT DAILY FOR SEVERAL MONTHS. SHE STATED THE BALLOON CAN BE BLOCKED WITH MAXIMUM 15 ML, BUT IT WAS NOTED SHE HAD NOT READ THE INSTRUCTIONS FOR USE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019001 ↗
• MalfunctionJan 5, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, BEFORE INSERTION, AN INFLATION TEST WAS DONE WITH NO PROBLEM. AFTER A FEW HOURS INDWELLING, THE CATHETER FELL OFF. A BALLOON BURST WAS FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11117273 ↗
• MalfunctionJun 10, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST UPON INFLATION WHEN ATTEMPTING TO INSERT CATHETER. IT WAS REPORTED THAT HOSPITAL POLICY AND CATHETER INSTRUCTIONS WERE FOLLOWED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140362 ↗
• InjuryAug 16, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION RECEIVED INDICATED A PIECE OF METAL WAS STICKING OUT THE TIP OF THE CATHETER. THE PATIENT'S MOTHER INSERTS THE CATHETERS HERSELF (AND SHE REPORTED THAT SHE WAS TRAINED TO DO SO). THE METAL CAUSED SOME BLEEDING. SHE SPOKE WITH A NURSE ON THE PHONE BUT NO MEDICAL ATTENTION WAS NEEDED. THE ISSUE HAS SINCE BEEN RESOLVED.

  Patient problems: Blood Loss

  MAUDE report 8902994 ↗
• InjuryJul 11, 2017Leak/Splash; Burst Container or Vessel; Fluid/Blood Leak; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, A (B)(6) PATIENT IN CHARGE FOR ABDOMINAL TRAUMA DURING A RUGBY SHOCK. FOLLOWING THE PLACEMENT OF A VESICAL CATHETER BECAUSE OF THE PRESENCE OF A VESICAL GLOBE, THE PATIENT FELT A PAIN ALONG THE PENIS. AFTER CHECKING THE CATHETER , THE NURSE SAW THAT THERE IS A LEAK IN THE MEATUS AND THAT THERE IS NO LIQUID IN THE BALLOON DURING THE DEFLATION. AFTER WITHDRAWAL OF THE CATHETER , DECIDED BY THE DOCTOR , IT TURNS OUT THAT THE BALLOON BURST. THE BLADDER CATHETER HAD TO BE REMOVED EARLY CAUSED PAIN FOR THE PATIENT AND WAS INEFFECTIVE. IN ADDITION, THERE IS A RISK OF LESIONS OF THE UROGENITAL WAYS.

  Patient problems: Pain

  MAUDE report 6702949 ↗
• InjuryApr 6, 2017Material Protrusion/Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, END-USER REPORTED TO DISTRIBUTOR THAT THERE WAS A WIRE STICKING OUT OF THE TIP OF THE FOLEY CATHETER. EU DID NOT USE THE ITEM.

  Patient problems: No Information

  MAUDE report 6463858 ↗
• MalfunctionApr 4, 2017Material Protrusion/Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT NOTICED A WIRE STICKING OUT OF THE TIP OF THE FOLEY CATHETER BEFORE USE. THEY DID NOT USE THE ITEM.

  Patient problems: No Patient Involvement

  MAUDE report 6457885 ↗
• MalfunctionMay 23, 2016Difficult to Insert

  ACCORDING TO THE AVAILABLE INFORMATION, DURING A URINARY CATHETER A FIRST CATHETERIZATION, CATHETER COULD NOT BE PLACED BECAUSE OF THE IMPOSSIBILITY OF REMOVE THE STYLET. A SECOND ATTEMPT TO IMPLANT A CATHETER IS CARRIED OUT WITH ANOTHER CATHETER SAME LOT. THIS ALSO FAILED, THE STYLET HAD TO BE FORCIBLY REMOVED. THIS SECOND CATHETER WAS FINALLY IMPLEMENTED SUCCESSFULLY WITHOUT STYLET. NO CLINICAL CONSEQUENCES WERE REPORTED. HOWEVER THIS INCIDENT HAS CAUSED AN INCREASE IN TIME OF THE INTERVENTION: 1 HOUR INSTEAD OF 15 MINUTES. AN INFECTIOUS RISK EXISTED AT THAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5674110 ↗