Porges ColoplastRecalls & reported problems across all models
Coloplast A/S · 79 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Porges Coloplast model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 563
- Deaths reported
- 1
- Injuries reported
- 138
- Recalls
- 3
We found 79 models of Porges Coloplast by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 563 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2015 and Apr 9, 2026 — classified as 1 death, 138 injuries, 424 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (188 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Porges Coloplast recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 2, 2024Open, Classified
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0845-2025 · Root cause: Packaging · names 27 of these models · Recall details · FDA record ↗
- Dec 2, 2024Open, Classified
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0844-2025 · Root cause: Packaging · names 32 of these models · Recall details · FDA record ↗
- Mar 11, 2024Open, Classified
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Z-1463-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Porges Coloplast problems
Device problems
- Burst Container or Vessel188
- Material Rupture52
- Deflation Problem37
- Failure to Deflate28
- Break27
- Device Contamination with Chemical or Other Material24
- Fluid/Blood Leak23
- Fracture17
Patient problems
- No Clinical Signs, Symptoms or Conditions291
- Pain64
- No Known Impact Or Consequence To Patient62
- No Information29
- Insufficient Information21
- Urinary Retention19
- Discomfort18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
Porges Coloplast models
79 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Porges Coloplast AA6114CATHETER, RETENTION TYPE, BALLOON1 recall1 death68 reports
- Porges Coloplast AA6116CATHETER, RETENTION TYPE, BALLOON1 recall67 reports
- Porges Coloplast AB6318CATHETER, RETENTION TYPE, BALLOON1 recall45 reports
- Porges Coloplast AB6322CATHETER, RETENTION TYPE, BALLOON1 recall34 reports
- Porges Coloplast AB6320CATHETER, RETENTION TYPE, BALLOON1 recall32 reports
- Porges Coloplast AA6106CATHETER, RETENTION TYPE, BALLOON1 recall29 reports
- Porges Coloplast AA6118CATHETER, RETENTION TYPE, BALLOON1 recall29 reports
- Porges Coloplast AA6112CATHETER, RETENTION TYPE, BALLOON1 recall28 reports
- Porges Coloplast AA6120CATHETER, RETENTION TYPE, BALLOON1 recall22 reports
- Porges Coloplast AA6110CATHETER, RETENTION TYPE, BALLOON1 recall19 reports
- Porges Coloplast AA6316CATHETER, RETENTION TYPE, BALLOON1 recall16 reports
- Porges Coloplast AA6314CATHETER, RETENTION TYPE, BALLOON1 recall13 reports
- Porges Coloplast AA6418CATHETER, RETENTION TYPE, BALLOON1 recall13 reports
- Porges Coloplast AA6108CATHETER, RETENTION TYPE, BALLOON1 recall12 reports
- Porges Coloplast AA6318CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AA6416CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AB6118CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AB6120CATHETER, RETENTION TYPE, BALLOON1 recall9 reports
- Porges Coloplast AB6222CATHETER, RETENTION TYPE, BALLOON1 recall8 reports
- Porges Coloplast AB6324CATHETER, RETENTION TYPE, BALLOON1 recall8 reports
- Porges Coloplast AA6414CATHETER, RETENTION TYPE, BALLOON1 recall7 reports
- Porges Coloplast AB6022CATHETER, RETENTION TYPE, BALLOON1 recall6 reports
- Porges Coloplast AA6C18CATHETER, RETENTION TYPE, BALLOON1 recall4 reports
- Porges Coloplast AA6122CATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- Porges Coloplast AA6312CATHETER, RETENTION TYPE, BALLOON1 recall3 reports
- Porges Coloplast AA6310CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AA6320CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AA6C20CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6024CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6A22CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6C20CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AB6C22CATHETER, RETENTION TYPE, BALLOON1 recall2 reports
- Porges Coloplast AA6308CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AA6410CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6124CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6220CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6224CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6420CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6A24CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AB6C18CATHETER, RETENTION TYPE, BALLOON1 recall1 report
- Porges Coloplast AA6124CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6322CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6324CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6408CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6412CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6420CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6422CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6424CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6C22CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AA6C24CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6122CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6418CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6422CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6424CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6522CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6524CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6A18CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6A20CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast AB6C24CATHETER, RETENTION TYPE, BALLOON1 recall0 reports
- Porges Coloplast RBD014DILATOR, CATHETER, URETERAL1 recall0 reports
- Porges Coloplast AEAD35Endoscopic guidewire, gastroenterology-urology7 reports
- Porges Coloplast ASP165LAVAGE, JET4 reports
- Porges Coloplast AXXL10endoscopic access overtube, gastroenterology-urology4 reports
- Porges Coloplast NBI070endoscopic injection needle, gastroenterology-urology3 reports
- Porges Coloplast AB6018CATHETER, RETENTION TYPE, BALLOON2 reports
- Porges Coloplast AB6020CATHETER, RETENTION TYPE, BALLOON2 reports
- Porges Coloplast AB6218CATHETER, RETENTION TYPE, BALLOON2 reports
- Porges Coloplast ASP185LAVAGE, JET2 reports
- Porges Coloplast BCHF61STENT, URETERAL2 reports
- Porges Coloplast BCHF74STENT, URETERAL2 reports
- Porges Coloplast AECD35Endoscopic guidewire, gastroenterology-urology1 report
- Porges Coloplast AE0E38Endoscopic guidewire, gastroenterology-urology1 report
- Porges Coloplast ASP145LAVAGE, JET1 report
- Porges Coloplast DOR424DISLODGER, STONE, BASKET, URETERAL, METAL1 report
- Porges Coloplast RBA008DILATOR, CATHETER, URETERAL1 report
- Porges Coloplast ACXL10endoscopic access overtube, gastroenterology-urology1 report
- Porges Coloplast ACP205CATHETER, URETERAL, GASTRO-UROLOGY1 report
- Porges Coloplast BCHF64STENT, URETERAL1 report
- Porges Coloplast BCHF65STENT, URETERAL1 report
Recent Porges Coloplast adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Burst Container or Vessel; Off-Label Use
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS ADMITTED FOR INDUCTION OF LABOR. WHEN FOLEY CATHETER INSERTED THROUGH CERVIX, 45MLS WATER PUT INTO BALLOON THEN IT THEN BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835330 ↗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 ↗MalfunctionMar 20, 2026Nonstandard Device
ACCORDING TO THE AVAILABLE INFORMATION A MANUFACTURING DEFECT HAS BEEN DETECTED IN COLOPLAST PEDIATRIC URINARY CATHETERS BEFORE USE. THE GUIDE WIRE PROTRUDES FROM THE TIP OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654810 ↗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 22, 2025Difficult to Remove; Difficult to Remove
ACCORDING TO THE AVAILABLE INFORMATION DIFFICULTY REMOVING THE MANDREL, IT SEEMED STUCK TO THE PROBE. THE NURSE HAD TO FORCE IT OUT, WHICH CAUSED PAIN AND DISCOMFORT.
Patient problems: Discomfort; Pain
MAUDE report 23863226 ↗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 ↗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 26, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION WHILE INSERTING A URINARY CATHETER INTO A CHILD FOR A CYSTOGRAPHY, DIFFICULTY WAS ENCOUNTERED IN PASSING THE BLADDER SPHINCTER, AS THE CHILD WAS PARTICULARLY UNDER TENSION. THE CATHETER BALLOON, WHICH HAD BEEN TESTED PRIOR TO INSERTION AND FOUND TO BE INTACT, WAS INFLATED WITHOUT ANY APPARENT DIFFICULTY. WHEN THE MANDREL WAS REMOVED, UNUSUAL RESISTANCE WAS OBSERVED, ASSOCIATED WITH TORSION OF THE CATHETER TIP. THE CATHETER WAS REMOVED BY EXERCISING ABOVE-NORMAL FORCE. DURING THE RADIOLOGICAL EXAMINATION, THE RADIOLOGIST NOTED THAT THE CATHETER WAS NOT IN PLACE AND THAT THE BALLOON WAS INFLATED AT THE LEVEL OF THE URETHRA. THE CATHETER WAS THEN REMOVED IN THE RADIOLOGY DEPARTMENT. THE INCIDENT LED TO THE POSTPONEMENT OF THE PATIENT'S EXAMINATION.
Patient problems: Insufficient Information
MAUDE report 23658326 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION A HAIR WAS FOUND ON THE INSIDE OF THE UNOPENED PEEL PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656021 ↗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 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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