Porges Coloplast AA6118Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03600040127605), received between Jun 2, 2016 and Dec 10, 2024 — classified as 12 injuries, 17 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT HAD BEEN CATHETERIZED FOR MORE THAN A WEEK AND EXPERIENCED URINARY MEATUS ESCHAR AND AN ULCER.

  Patient problems: Pressure Sore/Ulcer; Ulcer

  MAUDE report 20892690 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT HAD BEEN CATHETERIZED FOR MORE THAN A WEEK AND EXPERIENCED URINARY MEATUS ESCHAR AND AN ULCER.

  Patient problems: Pressure Sore/Ulcer; Ulcer

  MAUDE report 20892684 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT HAD BEEN CATHETERIZED FOR MORE THAN A WEEK AND EXPERIENCED URINARY MEATUS ESCHAR AND AN ULCER.

  Patient problems: Pressure Sore/Ulcer; Ulcer

  MAUDE report 20892634 ↗
• MalfunctionAug 27, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLON BURST. THIS OCCURRED ON A DOZEN DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078302 ↗
• MalfunctionMay 21, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION WHEN THE CATHETER WAS PLACED THE BALLOON BURST IN THE PATIENT'S BLADDER. THE CATHETER AND BALLOON WERE REMOVED. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358906 ↗
• MalfunctionSep 30, 2023Complete Blockage; Complete Blockage

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE'S BALLOON NEEDED TO BE DEFLATED AND REINFLATED TO EMPTY THE BLADDER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 17849131 ↗
• MalfunctionSep 5, 2023Failure to Deflate; Failure to Deflate

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD INFLATION AND DEFLATION ISSUES. THE BALLOON WAS DIFFICULT TO INFLATE. THE PATIENT WAS CATHETERIZED TWICE. THE DEVICE WAS REMOVED AND WAS NOT ABLE TO BE DEFLATED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682805 ↗
• MalfunctionJun 2, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO PUNCTURE. THE BALLOON WAS PUNCTURED WHILE THE PATIENT WAS ASLEEP AFTER A PROSTATECTOMY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051702 ↗
• MalfunctionOct 2, 2022Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST DURING PLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526452 ↗
• MalfunctionOct 2, 2022Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST DURING PLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526448 ↗
• MalfunctionOct 2, 2022Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST DURING PLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526324 ↗
• MalfunctionFeb 3, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, 15 ML WAS INJECTED INTO THE BALLOON AFTER INSERTION AND THE BALLOON BURST. A NEW PRODUCT WAS USED ALTERNATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446538 ↗
• InjuryOct 20, 2021Difficult to Advance; Difficult to Advance

  ACCORDING TO THE AVAILABLE INFORMATION, DURING LOADING OF THE GUIDEWIRE, THE GUIDE WIRE DIDN'T SLIDE IN THE CATHETER, THUS THE GUIDE WIRE LOOPED IN THE EXTREMITY AND NEVER GOT OUT. THE REPLACEMENT OF THE CATHETER ASSISTED BY GUIDEWIRE CAN'T BE DONE AND FINISHED WITHOUT IT. CLINICAL CONSEQUENCES: USE OF CYSTOCATH, SO HEAVY PAIN AND MOBILIZATION OF MEDICAL AND PARAMEDICAL STAFF, ULTRASOUND, ANESTHETIC GAS, ETC. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL," AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Pain

  MAUDE report 12668522 ↗
• InjuryOct 20, 2021Difficult to Advance; Difficult to Advance

  ACCORDING TO THE AVAILABLE INFORMATION, DURING LOADING OF THE GUIDEWIRE, THE GUIDE WIRE DIDN'T SLIDE IN THE CATHETER, THUS THE GUIDE WIRE LOOPED IN THE EXTREMITY AND NEVER GOT OUT. THE REPLACEMENT OF THE CATHETER ASSISTED BY GUIDEWIRE CAN'T BE DONE AND FINISHED WITHOUT IT. CLINICAL CONSEQUENCES: USE OF CYSTOCATH, SO HEAVY PAIN AND MOBILIZATION OF MEDICAL AND PARAMEDICAL STAFF, ULTRASOUND, ANESTHETIC GAS, ETC. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL," AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Pain

  MAUDE report 12668342 ↗
• InjuryOct 19, 2021Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DID NOT FULLY DEFLATE DURING WITHDRAWAL AND CREATED A PLEATED BULGE THAT INCREASED THE DIAMETER AND "CREATED SOME RELIEF." THE PATIENT EXPERIENCED PAIN DURING WITHDRAWAL "LINKED BY THE GRIP" AND BLEEDING OF THE "INTERNAL HOLE." TRIGGERING OF AUTONOMIC HYPER REFLEXIA WAS ALSO REPORTED. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL" AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 12656648 ↗
• InjuryOct 19, 2021Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DID NOT FULLY DEFLATE DURING WITHDRAWAL AND CREATED A PLEATED BULGE THAT INCREASED THE DIAMETER AND "CREATED SOME RELIEF." THE PATIENT EXPERIENCED PAIN DURING WITHDRAWAL "LINKED BY THE GRIP" AND BLEEDING OF THE "INTERNAL HOLE." TRIGGERING OF AUTONOMIC HYPER REFLEXIA WAS ALSO REPORTED. IT WAS NOTED "USE OF A LOT OF XYLOCAINE GEL" AND THAT THE CAUSE OF THE EVENT WAS THE PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 12656498 ↗
• InjurySep 8, 2021Difficult to Remove; Difficult to Remove

  DESCRIPTION: (B)(6). IMPOSSIBILITÉ D'ENLEVER LA SONDE URINAIRE DANS LE SERVICE D'UROLOGIE. LE CATHÉTER A DÛ ÊTRE RETIRÉ AU BLOC SOUS ANESTHÉSIE GÉNÉRALE. DOULEURS IMPORTANTES POUR LE PATIENT, MOBILISATION DES ÉQUIPES CHIRURGICALES ET RADIOLOGIQUES. TRANSLATION OF DESCRIPTION OF THE INCIDENT BY THE CUSTOMER: IMPOSSIBILITY TO WITHDRAW THE URINARY CATHETER IN THE UROLOGY DEPARTMENT. THE CATHETER HAD TO BE REMOVED IN AN OPERATING ROOM UNDER GENERAL ANESTHESIA. THE PATIENT FELT SIGNIFICANT PAIN, MOBILIZATION OF SURGICAL AND RADIOLOGICAL TEAMS.

  Patient problems: Pain

  MAUDE report 12443076 ↗
• MalfunctionJan 7, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST WHEN CHANGING THE CATHETER. THERE WAS NO HARM TO THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11132104 ↗
• InjuryAug 6, 2020Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, THE TIP OF THE CATHETER HAD A PICK WHICH DAMAGED THE INTERNAL LOBE TISSUES AT THE INSERTION, RESULTING IN URETHRORRHAGIA.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 10372606 ↗
• MalfunctionDec 13, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER BALLOON BURST WHILE INSERTED, AND THE CATHETER FELL OUT. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467959 ↗
• MalfunctionDec 13, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER BALLOON BURST WHILE INSERTED, AND THE CATHETER FELL OUT. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467958 ↗
• InjuryJun 14, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST, AND CATHETER CAME OUT FROM PATIENT. RISK OF INFECTION AND REST OF BALLOON IN THE BLADDER.

  Patient problems: No Information

  MAUDE report 8699430 ↗
• InjuryJun 14, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST, AND CATHETER CAME OUT FROM PATIENT. RISK OF INFECTION AND REST OF BALLOON IN THE BLADDER.

  Patient problems: No Information

  MAUDE report 8699427 ↗
• MalfunctionApr 17, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, DURING THE TEST OF THE BALLOON WITH 15ML OF WATER FOR INJECTION, THE BALLOON BUSTS BEFORE INSERTION. NOT USED ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524331 ↗
• MalfunctionJan 13, 2017Device Operates Differently Than Expected

  ACCORDING TO THE INFORMATION RECEIVED, PATIENT FEELS PAIN AT BLADDER WITH THE CATHETER AND URGES TO URINATE BUT DOES NOT SUCCEED. AFTER WITHDRAWAL OF THE CATHETER, THE PATIENT IMMEDIATELY URINATES 700 ML.

  Patient problems: Micturition Urgency; Pain

  MAUDE report 6249685 ↗