Porges Coloplast AA6106Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03600040126844), received between Sep 18, 2015 and Mar 19, 2025 — classified as 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Burst Container or Vessel; Fracture; Failure to Unfold or Unwrap; Burst Container or Vessel; Fracture; Failure to Unfold or Unwrap

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN FILLING THE BALLOON TO 1.5 ML, THERE WAS AN ACCIDENTAL EXIT OF THE BLADDER CATHETER AND A RUPTURE OF THE BALLOON AND TIP. THE TIP WAS MISSING AND ESTIMATED TO BE APPROXIMATELY 1 CM IN SIZE. THE PATIENT UNDERWENT TWO INTRAOPERATIVE X-RAYS AND AN EXPLORATORY CYSTOSCOPY. NO FOREIGN BODY WAS FOUND. THE EXTRA PROCEDURES AND THE GENERAL ANESTHESIA TIME ADDED LENGTH TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643497 ↗
• InjuryFeb 19, 2025Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, 6 FRENCH FOLEY WAS PLACED INTO THE PATIENT, INFLATED AND PULLED BACK ON THE LINE TO MAKE SURE THAT THE BALLOON AND THE FOLEY WAS SECURE AND THE FOLEY CAME OUT BUT THE BALLOON AND THE END OF THE FOLEY WAS NOT INTACT. PIECES OF THE FOLEY REMAIN INSIDE OF THE PATIENT'S BLADDER. UNABLE TO LOCATE MISSING FRAGMENT OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415982 ↗
• InjurySep 11, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PEDIATRIC CATHETERS BROKE OFF ON TWO OCCASIONS RIGHT AT THE PORTION WHERE THE CATHETER BAG CONNECTOR AND THE SHAFT OF THE CATHETER MEETS. IT BROKE OFF IN THE PATIENT AND PATIENT HAD TO BE TAKEN TO THEATRE FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191536 ↗
• InjurySep 11, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PEDIATRIC CATHETERS BROKE OFF ON TWO OCCASIONS RIGHT AT THE PORTION WHERE THE CATHETER BAG CONNECTOR AND THE SHAFT OF THE CATHETER MEETS. IT BROKE OFF IN THE PATIENT AND PATIENT HAD TO BE TAKEN TO THEATRE FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191130 ↗
• MalfunctionJul 18, 2024Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION THE TIP OF THE CATHETER IS BEVELED INSTEAD OF A STRAIGHT ROUNDED TIP. THE DEVICE WAS USED ON A NEONATE. THE TIP WAS FOUND ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19773777 ↗
• InjuryFeb 29, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO ADDITIONAL AVAILABLE INFORMATION, THE INDICATION FOR CATHETERIZATION WAS MAG3 SCINTIGRAPHY UNDER CATHETERIZATION. URINARY MEATUS WAS THE CHOSEN ROUTE OF CATHETERIZATION, AND THE BALLOON WAS NOT TESTED BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809123 ↗
• MalfunctionFeb 27, 2024No Flow; No Flow

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON WAS CHECKED BEFORE THE CATHETER WAS INSERTED. THE NURSE REALIZED THAT THE URINARY CATHETER WAS LEAKING DURING THE FIRST TREATMENTS OF THE DAY. THE NURSING TEAM CONCLUDED THAT THERE IS A VERY STRONG SUSPICION THAT THE BALLOON IS PUNCTURED AND NON-POROUS. THE CATHETER WAS REMOVED IMMEDIATELY. A NEW URINARY CATHETER HAD TO BE REINSERTED.

  Patient problems: Urinary Retention

  MAUDE report 18791333 ↗
• InjuryJan 25, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON WAS UNABLE TO BE DEFLATED. CATHETER WAS CUT TO TRY TO DEFLATE THE BALLOON BUT FAILED. CUT CATHETER WAS LEFT IN PLACE. BALLOON WAS DEFLATED UNDER ULTRASOUND BY PIERCING IT USING A SUPRAPUBIC KT. THE CATHETER WAS ABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581911 ↗
• MalfunctionJan 3, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE AVAILABLE INFORMATION BLADDER GLOBES ON REPEATING CATHETERS.

  Patient problems: Urinary Retention

  MAUDE report 18435453 ↗
• MalfunctionSep 21, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS DIFFICULT TO DEFLATE. IN AN ATTEMPT TO REMOVE THE DEVICE, THE BALLOON WAS NOT DEFLATING DESPITE THE CATHETER BEING CUT IN HALF. THE UROLOGIST PUNCTURED THE BALLOON USING A GUIDEWIRE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795978 ↗
• MalfunctionMay 11, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REMOVAL DUE TO A BALLOON BURST. THE BALLOON WAS NOT CHECKED FOR INFLATION OR DEFLATION BEFORE PLACEMENT BECAUSE THE USER DID NOT INTEND TO INFLATE IT. THEY ONLY WANTED TO PERFORM AN EVACUATING CATHETERIZATION, BUT THEY DID NOT HAVE THE RIGHT SIZED DEVICE AVAILABLE. THE FLOW WAS VERY SLOW SO THE BALLOON WAS INFLATED ABOUT 10 MINUTES. AFTER VARIOUS ATTEMPTS TO DEFLATE THE BALLOON (2 ML, 1 ML, 20 ML SYRINGE, LL), HE FINALLY ADDED 0.5 ML OF STERILE WATER IN THE BALLOON (I.E. 2 ML INSTEAD OF 1.5 ML) AND THE BALLOON BURST. THE USER WAS ABLE TO REMOVE THE DEVICE WITHOUT ANY PROBLEM. NO PIECE OF BALLOON REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913399 ↗
• MalfunctionFeb 24, 2023Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REPORTED TO HAVE PART OF THE DEVICE BREAKING OFF. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435902 ↗
• MalfunctionOct 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A HAIR IN THE PACKAGING. WHILE OPENING THE PACKAGING IN THE OPERATING ROOM, A HAIR WAS FOUND IN THE SEALED PACKAGING. THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699692 ↗
• InjuryJun 29, 2022Break; Failure to Deflate; Break; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO FAILURE TO DEFLATE. THE DEVICE WAS NOT ABLE TO DEFLATE SO IT WAS RUPTURED AND REMOVED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849400 ↗
• InjurySep 8, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS PLACED WITHOUT DIFFICULTY OF RESISTANCE. THE BALLOON WAS INFLATED WITH 1.5 MILLILITERS OF STERILE WATER AND A COLLECTION BAG WAS ATTACHED. THE CATHETER FELL OUT OF THE PATIENT. UPON CLOSER INSPECTION, THE TIP OF THE CATHETER WAS NO LONGER INTACT; THE TIP BROKE. A BLADDER IRRIGATION AND CYSTOSCOPY WERE PERFORMED. THERE WAS NO EVIDENCE OF THE CATHETER REMNANT. A SECOND CATHETER WAS PLACED WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439880 ↗
• MalfunctionAug 25, 2021Blocked Connection; Blocked Connection

  ACCORDING TO AVAILABLE INFORMATION, THE BALLOON DEFLATED AND A BLOCKAGE AT THE DEFLATED BALLOON WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE. THE COMPLAINT INDICATES THIS ISSUE OCCURRED 4 TIMES, THUS 4 TOTAL RELATED COMPLAINTS EXIST: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365891 ↗
• MalfunctionAug 25, 2021Blocked Connection; Blocked Connection

  ACCORDING TO AVAILABLE INFORMATION, THE BALLOON DEFLATED AND A BLOCKAGE AT THE DEFLATED BALLOON WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE. THE COMPLAINT INDICATES THIS ISSUE OCCURRED 4 TIMES, THUS 4 TOTAL RELATED COMPLAINTS EXIST: (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365836 ↗
• MalfunctionAug 25, 2021Blocked Connection; Blocked Connection

  ACCORDING TO AVAILABLE INFORMATION, THE BALLOON DEFLATED AND A BLOCKAGE AT THE DEFLATED BALLOON WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE. THE COMPLAINT INDICATES THIS ISSUE OCCURRED 4 TIMES, THUS 4 TOTAL RELATED COMPLAINTS EXIST: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365716 ↗
• MalfunctionAug 24, 2021Deflation Problem; Blocked Connection; Deflation Problem; Blocked Connection

  ACCORDING TO AVAILABLE INFORMATION, THE BALLOON DEFLATED AND A BLOCKAGE AT THE DEFLATED BALLOON WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE. THE COMPLAINT INDICATES THIS ISSUE OCCURRED 4 TIMES, THUS 4 TOTAL RELATED COMPLAINTS EXIST: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362829 ↗
• InjuryAug 24, 2021Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS DAMAGED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362435 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A FULL-TERM NEONATE WAS CATHETERIZED WITH MANDREL IN PLACE. THE CATHETER WAS EASILY ASSEMBLED AND THE BALLOON WAS INFLATED. ON REMOVAL OF THE MANDREL, THE PATIENT EXPERIENCED TRANSITORY HEMATURIA AND SPONTANEOUS DIURESIS. THE CATHETER WAS REMOVED AND THE PATIENT WAS TREATED WITH AN INJECTION OF EXACYL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematuria

  MAUDE report 11727484 ↗
• MalfunctionJan 5, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE CATHETER WAS DEFLATED FOR REMOVAL, THE BALLOON FOLDED UP INCORRECTLY ON ITSELF. THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT (A CHILD), IT WAS ALSO PAINFUL FOR HIM. FINALLY, A DOCTOR HAD TO REMOVE IT.

  Patient problems: Pain

  MAUDE report 11119778 ↗
• MalfunctionAug 2, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS IN THE PATIENT FOR 3 WEEKS (PATIENT NOT MOBILE). BALLOON HAS BEEN DEBLOCKED ONCE A WEEK AND THEN FILLED AGAIN WITH UROMED 10% GLYCERIN PLUS DISTILLED WATER. IN THE 3RD WEEK AFTER DEBLOCKING BALLOON BURST. NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856395 ↗
• MalfunctionMay 31, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS VERY AGILE IN HIS BED, SO THE CATHETER RUPTURED. PER HOSPITAL, NO INCIDENT, BECAUSE THE CATHETER WAS BROKEN ABOVE THE BRANCH OF THE CATHETER SHAFT - OUTSIDE THE BODY, AND COULD BE EASILY REMOVED.

  Patient problems: No Information

  MAUDE report 8660650 ↗
• InjuryFeb 20, 2019Positioning Problem; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, NOTHING DIFFERENT WAS NOTICED ABOUT THE CATHETER. THE CATHETER WAS INSERTED A COUPLE OF MILLIMETERS, SOME RESISTANCE WAS FELT AND THE CATHETER COULDN'T BE INSERTED FURTHER. THE CATHETER WAS REMOVED IMMEDIATELY AND A FEW DROPS OF BLOOD WAS VISIBLE. A SMALL STOMACH PROBE WAS INSERTED AND THAT STOPPED THE BLEEDING. BABY IS DOING WELL.

  Patient problems: Blood Loss

  MAUDE report 8353195 ↗