Porges Coloplast AB6322Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 03600040144442), received between Jul 1, 2016 and Apr 2, 2026 — classified as 4 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (17 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-0845-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON WAS INFLATED TO THE PRESSURE STATED ON THE TECHNICAL SHEET. THE FILLING BALLOON FOR CATHETER ADJUSTMENT BREAKS, AND IT COMES OUT WHILE CONTROLLING THE BALLOON FILLING PRESSURE ACCORDING TO THE TECHNICAL SHEET INSTRUCTIONS. THE BALLOON BROKE ON TWO OCCASIONS AND FROM DIFFERENT LOTS IN THE SAME PATIENT. OCCURRED IN THE OPERATING ROOM AFTER SURGERY AND ON THE WARD WHEN REPLACING THE ONE PREVIOUSLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767252 ↗
• MalfunctionDec 22, 2025Burst Container or Vessel; Unintended Deflation; Burst Container or Vessel; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION MALFUNCTIONED DURING PATIENT USE; THE BALLOON DEFLATED AND TORE NEAR THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863729 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION BREAKAGE OF THE CONNECTION CHANNEL TO THE IRRIGATION SYSTEM WHILE IRRIGATING WITH THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779954 ↗
• InjuryNov 19, 2025Tear, Rip or Hole in Device Packaging; Unintended Deflation; Tear, Rip or Hole in Device Packaging; Unintended Deflation

  A NEW 22 FR 3-WAY CATHETER WITH A 10ML BALLOON WAS INSERTED. A BALLOON PATENCY TEST WAS PERFORMED BEFORE INSERTION. LATER THAT SAME NIGHT, THE CATHETER WAS FOUND OUTSIDE THE URETER, WITH THE BALLOON DEFLATED. THE PATIENT STATED THAT HE HAD NOT TOUCHED IT. THIS WAS THE SECOND BALLOON DEFLATION IN TWO NIGHTS. AFTER TWO BALLOON DEFLATIONS, THE SURGEON SUSPECTED SILICONE POROSITY. DURING THE NIGHT OF (B)(6): PATIENT WITH A FEVER OF 38°C AT 9:45 PM. THE MEDICAL TEAM ADMINISTERED MEDICATION TO STOP THE INFECTION AND LOWER THE TEMPERATURE. CHECKS AT 10:50 PM: 38.4°C; 2:00 AM: 37.9°C; 5:00 AM: 37.5°C. AT 5:00 AM, THE PATIENT COMPLAINED OF FEELING COLD AND WAS GIVEN A DUVET AND FLEECE BLANKET, AND THE ROOM HEATING WAS INCREASED. ON DECEMBER 6TH AT 8:30 AM, THE PATIENT WAS SHIVERING, WITH A TEMPERATURE OF 41.1°C AND OXYGEN DESATURATION AT 86%. THE PATIENT WAS LESS ALERT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR SEPTIC DISCHARGE.

  Patient problems: Septic Shock

  MAUDE report 23596209 ↗
• MalfunctionAug 11, 2025Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT HAD AN SV 3-WAY WITH FLUSHES AND THE NURSE INTENDED TO PERFORM A QUICK FLUSH. AS SOON AS THE FLUSH WAS INITIATED, THE PATIENT INFORMED THERE WAS A LEAK NEXT TO THE SV. THE NURSE SAW THAT THE CATHETER HAD COME OUT AND THAT THE BALLOON APPEARED DEFLATED BUT INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771969 ↗
• MalfunctionJun 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  ACCORDING TO THE AVAILABLE INFORMATION DIRT WAS FOUND INSIDE THE PACKAGING. THE DEVICE WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235743 ↗
• MalfunctionJan 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE AVAILABLE INFORMATION, AS THE HOSPITAL OPENED A PACKAGE THERE WAS A HAIR (POSSIBLY EYEBROW OR LASH) INSIDE ONE OF THE STERILE PACKAGES. THE PACKAGE WAS SEALED AND NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116419 ↗
• InjuryDec 31, 2024Tear, Rip or Hole in Device Packaging; Unintended Deflation; Tear, Rip or Hole in Device Packaging; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A 3-WAY CATHETER PLACED IN THE OPERATION ROOM. DURING THE NIGHT, THE CATHETER WAS FOUND OUTSIDE WITH THE BALLOON DEFLATED AND FLAT. A NEW PLACEMENT OF A 3-WAY CATHETER WAS COMPLETED. PERMEABILITY TEST WAS DONE BEFORE PLACEMENT. LATER THE SAME NIGHT, THE CATHETER WAS AGAIN FOUND OUTSIDE WITH THE BALLOON DEFLATED. THE PATIENT INDICATED THAT HE DID NOT TOUCH IT. AFTER TWO DEFLATIONS OF THE BALLOON, THE SURGEON SUSPECTED THE POROSITY OF THE SILICONE. ON THE NIGHT OF 5 TO 6.5 DECEMBER: THE PATIENT DEVELOPED A FEVER AT 38 DEGREES CELSIUS AT 9:45 PM. THE MEDICAL TEAM GIVES THE PATIENT MEDICATION TO STOP THE INFECTION AND LOWER THE TEMPERATURE. PATIENT WAS CHECKED AT 10:50 P.M. 38.4 DEGREES CELSIUS, 2 A.M. 37.9 DEGREES CELSIUS, 5 A.M. 37.5 DEGREES CELSIUS, AT 5 A.M. THE PATIENT COMPLAINS OF BEING COLD AND IS COVERED WITH A DUVET + FLEECE BLANKET + ROOM HEATING INCREASED. ON 6 DECEMBER AT 8:30 A.M. THE PATIENT WAS SHIVERING T° 41.1 DESATURATION TO 86%, PATIENT LESS PRESENT. PATIENT WAS TRANSFERED TO CONTINUOUS CARE FOR SEPTIC DISCHARGE.

  Patient problems: Septic Shock

  MAUDE report 21048700 ↗
• MalfunctionAug 6, 2024Material Rupture; Material Rupture

  ACCORDING TO THE AVAILABLE INFORMATION, AFTER SURGERY, THE BALLOON WAS IMPLANTED WITH 20 CC OF FIXATIVE WATER BUT AFTER A FEW HOURS, THE BALLOON BURST AND FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924416 ↗
• MalfunctionAug 6, 2024Material Split, Cut or Torn; Unintended Deflation; Material Split, Cut or Torn; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT RECEIVED A NEW FLUSHING CATHETER AT THE UROLOGY OUTPATIENT CLINIC IN THE MORNING AROUND 10:30 AM. AT 12:30 PM THE CATHETER WAS NEXT TO THE PATIENT. THE PATIENT WAS SITTING ON THE EDGE OF THE BED. THE BALLOON OF THE CATHETER WAS DEFLATED. WHEN EXAMINING THE CATHETER, IT APPEARS THAT THE INJECTION POINT FOR THE BALLOON HAS BEEN COMPLETELY TORN OFF, CAUSING WATER TO ESCAPE FROM THE BALLOON AND THE CATHETER TO FALL OUT. A NEW FLUSHING CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923769 ↗
• MalfunctionJul 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE AVAILABLE INFORMATION A HAIR WAS FOUND INSIDE THE PACKAGING MAKING THE PRODUCT NON-STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668407 ↗
• MalfunctionJul 3, 2024Burst Container or Vessel; Off-Label Use; Burst Container or Vessel; Off-Label Use

  ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON FAILED ONCE INSERTED AND A HOLE WAS DISCOVERED. THE PATIENT WAS RE-INSERTED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666709 ↗
• MalfunctionJan 4, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION DURING UNCLOTTING, THE SAD LEAKS AND MOVES ABNORMALLY. A FEW MOMENTS LATER, THE PATIENT TRIED TO GET UP SLIGHTLY IN BED AND THE SAD CAME OUT BY ITSELF. THE BALLOON WAS FOUND TO BE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445928 ↗
• MalfunctionDec 26, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER BALLOON SPLIT THIS MORNING AFTER MANUAL CLOT REMOVAL WITH A SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394683 ↗
• MalfunctionJun 8, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088059 ↗
• MalfunctionDec 9, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. THE BALLOON WAS INFLATED WITH 50 ML OF SOLUTION AND BURST. THE DEVICE WAS REPLACED IN THE RECOVERY ROOM. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955315 ↗
• MalfunctionNov 4, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REMOVED DUE TO A BURST. DURING CATHETERIZATION FOR A FLUSHING, THE DEVICE RUPTURED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729888 ↗
• MalfunctionOct 25, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. THREE DEVICES BURST AND FELL OUT AFTER PLACEMENT AND BALLOON TEST. ONE DEVICE HAD ITS BALLOON INFLATED WITH 45 ML OF STERILE WATER. ANOTHER BALLOON BURST DURING THE TEST WITH 20 ML OF STERILE WATER. THE PATIENT PRESENTED WITH HEMATURIA AFTER REPEATED ATTEMPTS AT PLACEMENT. A DEVICE WAS SUCCESSFULLY PLACED WITHOUT ANY PROBLEM.

  Patient problems: Hematuria

  MAUDE report 15670340 ↗
• InjuryMay 31, 2022Break; Break

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED DUE TO THE CATHETER FALLING OFF AND A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549888 ↗
• MalfunctionNov 18, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER FELL OFF AND A BALLOON BURST WAS FOUND. ANOTHER PRODUCT WAS USED ALTERNATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836822 ↗
• MalfunctionNov 16, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST AND THE CATHETER FELL OFF. ANOTHER PRODUCT WAS USED ALTERNATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824040 ↗
• MalfunctionNov 10, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A HAIR IN THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790932 ↗
• MalfunctionMay 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO THE AVAILABLE INFORMATION, A HAIR WAS FOUND INSIDE THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877079 ↗
• MalfunctionMay 11, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN TRYING TO INDWELL THE CATHETER, THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806532 ↗
• InjuryApr 6, 2021Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS DIFFICULTY INSERTING THE CATHETER AFTER A TURP PROCEDURE. NAMELY, DIFFICULTIES WITH FILLING THE BALLOON. AFTER FILLING THE BALLOON TO 50ML, NO FLOW OF RINSING FLUID, THEN NO POSSIBILITY OF REMOVING THE FLUID FROM THE BALLOON. THE PATIENT WAS BLEEDING, AND THE PROCEDURE WAS PROLONGED. IT WAS NOTED THAT SIMILAR PROBLEMS HAVE OCCURRED IN 95% OF CASES SINCE (B)(6) 2020.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11619094 ↗