Porges Coloplast AA6116Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 03600040127490), received between Nov 6, 2015 and Apr 21, 2025 — classified as 15 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (27 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST THE DAY AFTER THE CATHETER WAS INSERTED, AND THE CATHETER CAME OUT. THE PATIENT SUFFERED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875046 ↗
• MalfunctionOct 15, 2024Burst Container or Vessel; Material Separation; Burst Container or Vessel; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, THE TIP COMES OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456240 ↗
• InjuryOct 15, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, INDWELLING CATHETERIZATION FOR CAESAREAN SECTION AND THE CATHETER WAS INTACT WHEN CHECKED BEFORE CATHETERIZATION. THERE WAS DOUBT ABOUT A BLOCKED CATHETER DURING THE PROCEDURE (TRACES OF BLOOD BUT NO URINE). THE CATHETER WAS REMOVED AND REPLACED BY ANOTHER CATHETER. WE DISCOVERED THAT THE DISTAL END OF THE CATHETER (CUT CLEANLY AT THE DISTAL LIMIT OF THE BALLOON) WAS MISSING AT THE TIME OF REMOVAL. RISKS OF INFECTION, RISK OF ANAPHYLAXIS, NEW OPERATION FOR THE PATIENT WITH ANESTHETIC RISK, PSYCHOLOGICAL TRAUMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455562 ↗
• MalfunctionOct 15, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE AVAILABLE INFORMATION, INDWELLING CATHETERIZATION FOR CAESAREAN SECTION, THE CATHETER WAS INTACT AND CHECKED BEFORE CATHETERIZATION. DOUBT ABOUT A BLOCKED CATHETER DURING THE PROCEDURE (TRACES OF BLOOD BUT NO URINE), CATHETER REMOVED AND REPLACED BY ANOTHER CATHETER. IT WAS DISCOVERED THAT THE DISTAL END OF THE CATHETER (CUT CLEANLY AT THE DISTAL LIMIT OF THE BALLOON) WAS MISSING AT THE TIME OF REMOVAL. RISKS OF INFECTION, RISK OF ANAPHYLAXIS, NEW OPERATION FOR THE PATIENT WITH ANESTHETIC RISK, PSYCHOLOGICAL TRAUMA.

  Patient problems: Urinary Retention

  MAUDE report 20455025 ↗
• InjurySep 20, 2024Material Separation; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER PLACED FOR THE BLADDER DRAINAGE AND HYDRIC BALANCE, AFTER A SOFT INVOLUNTARY PATIENT TRACTION, IT BROKE. PART OF CATHETER REMAINED IN THE URINARY TRACT. IT WAS NECESSARY TO REMOVE THE PART THROUGH A CYSTOSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267502 ↗
• MalfunctionAug 30, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON HAS BROKEN IN MANY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107298 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, URINE LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086581 ↗
• MalfunctionAug 6, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION THE URINARY CATHETER WAS FOUND IN THE PROTECTION WITH THE BALLOON DEFLATED. THE BALLOON WAS FOUND PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924278 ↗
• MalfunctionJul 30, 2024Unintended Deflation; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON WAS FOUND IN THE BED WITH THE BALLOON DEFLATED. A SPLIT WAS FOUND IN THE BALLOON AND PATIENT NEEDED TO GO TO EMERGENCY TO BE RE-CATHETERIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861722 ↗
• MalfunctionJul 16, 2024Complete Blockage; Complete Blockage

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WILL NOT PASS LIQUID.

  Patient problems: Urinary Retention

  MAUDE report 19755329 ↗
• MalfunctionJun 20, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS CHECKED BEFORE USE BY INFLATING THE BALLOON BUT IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579462 ↗
• MalfunctionJun 18, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED BUT WAS FOUND IN THE PATIENT'S BED DUE TO A PIERCED BALLOON. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559544 ↗
• MalfunctionJun 18, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED IN THE SURGICAL ROOM BUT WAS FOUND IN THE PATIENT'S BED DUE TO A PIERCED BALLOON. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559530 ↗
• MalfunctionJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION PATIENT EXPERIENCED LEAKAGE AND PAIN FOLLOWING INSERTION OF THE CATHETER. THE CATHETER WAS REMOVED WITH VERIFICATION THE BALLOON WAS WELL INFLATED BUT NOT POSITIONED VERY WELL CAUSING AN OBSTRUCTION OF URINE CAUSING ANURIA.

  Patient problems: Discomfort; Pain; Urinary Retention

  MAUDE report 19482525 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION PATIENT EXPERIENCED LEAKAGE AND PAIN FOLLOWING INSERTION OF THE CATHETER. THE CATHETER WAS REMOVED WITH VERIFICATION THE BALLOON WAS WELL INFLATED BUT NOT POSITIONED VERY WELL CAUSING AN OBSTRUCTION OF URINE CAUSING ANURIA.

  Patient problems: Discomfort; Pain; Urinary Retention

  MAUDE report 19477420 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION PATIENT EXPERIENCED LEAKAGE AND PAIN FOLLOWING INSERTION OF THE CATHETER. THE CATHETER WAS REMOVED WITH VERIFICATION THE BALLOON WAS WELL INFLATED BUT NOT POSITIONED VERY WELL CAUSING AN OBSTRUCTION OF URINE CAUSING ANURIA.

  Patient problems: Discomfort; Pain; Urinary Retention

  MAUDE report 19477419 ↗
• MalfunctionJun 3, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE AVAILABLE INFORMATION URINARY LEAKAGE AND PAIN FOLLOWING THE INSERTION OF A CATHETER. THE CATHETER WAS REMOVED AND THE BALLOON WAS INFLATED AS EXPECTED. THE BALLOON WAS NOT POSITIONED WELL CAUSING THE URINE LEAKAGE.

  Patient problems: Urinary Retention

  MAUDE report 19447820 ↗
• MalfunctionApr 22, 2024Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION UPON TESTING, THE BALLOON DID NOT DEFLATE ONCE INFLATED. ANOTHER DEVICE WAS USED WITH NO PROBLEMS. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159546 ↗
• MalfunctionMar 25, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON POPPED ON 2 OR 3 DEVICES. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970223 ↗
• MalfunctionMar 25, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON POPPED ON 2 OR 3 DEVICES. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970219 ↗
• MalfunctionMar 25, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON POPPED ON 2 OR 3 DEVICES. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970211 ↗
• MalfunctionMar 7, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION AFTER THE URINARY CATHETER WAS PLACED, THE FOLLOWING DAY THE CATHETER WAS NO LONGER IN PLACE AND WAS FOUND THAT THE BALLOON WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861879 ↗
• InjuryFeb 21, 2024Unintended Deflation; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON LEAKED AND SLIPS OUT RESULTING IN A BLADDER INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 18751859 ↗
• MalfunctionOct 7, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. DURING INFLATION, THE BALLOON BURST IN THE PATIENT'S BLADDER. ANOTHER MANUFACTURER'S DEVICE WAS USED TO CATHETERIZE THE PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892573 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE NURSE AND THE CAREGIVER NOTICED BLEEDING IN A CATHETERIZED PATIENT'S PENIS AND THE ABSENCE OF URINE IN THE COLLECTING BAG. THE DEVICE CAME OUT OF THE PATIENT'S PENIS AND THE BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury; Urinary Retention

  MAUDE report 17795903 ↗