Porges Coloplast AA6120Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03600040127735), received between Oct 25, 2016 and Dec 1, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. LEAKS ON SAD IN THE GERIATRIC DEPARTMENT. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S SAD WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680970 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. LEAKS ON SAD IN THE GERIATRIC DEPARTMENT. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S SAD WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680267 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645665 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645633 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645379 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645281 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645153 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645036 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645010 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED FOR URINARY INCONTINENCE TO HELP HEAL BEDSORES. THERE WAS A LEAK ON THE INDWELLING CATHETER. URINE LEAKAGE WAS THROUGH THE URETHRA AND NOT OUTSIDE THE DEVICE. THE PATIENT'S CATHETER WAS REPLACED ON THE SAME DAY IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644955 ↗
• MalfunctionDec 3, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE URINARY CATHETER BALLOON WAS PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834699 ↗
• MalfunctionApr 22, 2024Unintended Deflation; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON WAS FOUND DEFLATED. A NEW CATHETER WAS INSERTED SUCCESSFULLY. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19157304 ↗
• MalfunctionNov 28, 2023Unintended Deflation; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION, ON DAY 1 OF THE PROSTATECTOMY THE CATHETER FELL OUT AND IT WAS OBSERVED THE BALLOON WAS DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221461 ↗
• MalfunctionJul 28, 2023Burst Container or Vessel; Burst Container or Vessel

  TO OUR KNOWLEDGE / UNDERSTANDING OF THE REPORTED EVENT, 1 PATIENT HAS BEEN INSERTED A FOLYSIL CATHETER. DURING THE DWELLING TIME, THE BALLOON BURST IN SITU, THE CATHETER FELL OUT, AND THE BALLOON WAS CUT IN TWO, WITHOUT REPORTED INJURY TO THE PATIENT NOR CYSTOSCOPY TO CHECK THE BLADDER AND REMOVE BALLOON FRAGMENTS, IF NEEDED. THE INCIDENT PROBABLY REQUIRED RE-INTERVENTION FOR CHANGE OF CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417136 ↗
• MalfunctionAug 26, 2022Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT USED DUE TO A BURST BALLOON. THE BALLOON BURST DURING THE INFLATION TEST BEFORE IT WAS PLACED IN A PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306423 ↗
• MalfunctionAug 26, 2022Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT USED DUE TO A BURST BALLOON. THE BALLOON BURST DURING THE INFLATION TEST BEFORE IT WAS PLACED IN A PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299947 ↗
• 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 12668530 ↗
• 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 12656794 ↗
• InjuryJul 28, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE AVAILABLE INFORMATION, DURING A ROBOT-ASSISTED INTERVENTION, THE TIP OF THE CATHETER BROKE (THE PART WITH EYELETS) AFTER EXERTING TRACTION. AN INTERVENTION WAS NECESSARY TO REMOVE THE BROKEN PIECE. THE PATIENT HAD TO BE RE-CATHETERIZED, WHICH RESULTED IN A 15-MINUTE EXTENSION OF THE PROCEDURE. THERE WERE NO OTHER CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238589 ↗
• 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. A FEW HOURS AFTER INDWELLING, THE CATHETER FELL OFF. A BALLOON BURST WAS FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11117768 ↗
• MalfunctionApr 25, 2019Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, DURING ITS INFLECTION THE BALLOON BURST. THEY REMOVED IT AND PLACES ANOTHER CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552179 ↗
• MalfunctionOct 25, 2016Burst Container or Vessel

  ACCORDING TO THE INFORMATION RECEIVED FROM AN END USER, A NURSE HAD INSERTED THE CATHETER INTO THE BLADDER OF THE PATIENT. THE BALLOON HAD BEEN INFLATED WITH 8 ML SALINE SOLUTION. FEW MINUTES AFTER, THE BALLOON HAD BURST. THE BALLOON APPEARED TO BE COMPLETE, AFTER THE CATHETER WAS REMOVED AND INSPECTED, SO NO PARTICLES OF THE BALLOON REMAINED IN THE BLADDER OR IN THE URETHRA. THE PATIENT WAS NOT HARMED, SO A NEW CATHETER HAD BEEN INSERTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6054151 ↗