AQUACEL AG EXTRARecalls & reported problems across all models
Convatec, Purchasing Department · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 7 models of AQUACEL AG EXTRA by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2017 and Aug 28, 2025 — classified as 2 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (36 reports).
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
Most reported AQUACEL AG EXTRA problems
Device problems
- Delivered as Unsterile Product36
- Unsealed Device Packaging30
- Packaging Problem18
- Contamination /Decontamination Problem3
- Device Damaged Prior to Use3
- Adverse Event Without Identified Device or Use Problem2
- Device Contamination with Chemical or Other Material2
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Patient Involvement14
- Anaphylactic Shock1
- Blister1
- Cellulitis1
- Cyanosis1
- Discharge1
- Dizziness1
AQUACEL AG EXTRA models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AQUACEL AG+ EXTRA 413568Dressing, Wound, Drug19 reports
- AQUACEL AG EXTRA 420677Dressing, Wound, Drug10 reports
- AQUACEL AG+ EXTRA 413569Dressing, Wound, Drug4 reports
- AQUACEL AG EXTRA 420676Dressing, Wound, Drug2 reports
- AQUACEL AG+ EXTRA 413566Dressing, Wound, Drug2 reports
- AQUACEL AG EXTRA 420675Dressing, Wound, Drug1 report
- AQUACEL AG EXTRA 420678Dressing, Wound, Drug1 report
Recent AQUACEL AG EXTRA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY DISTRIBUTOR AND END USER THAT THE SURFACE OF THE TWO DRESSINGS WAS DIRTY WHEN OPENED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910887 ↗MalfunctionAug 28, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY DISTRIBUTOR AND END USER THAT THE SURFACE OF THE TWO DRESSINGS WAS DIRTY WHEN OPENED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910886 ↗MalfunctionDec 2, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20816333 ↗InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Anaphylactic Shock; Blister; Cyanosis; Dizziness; Dyspnea; Itching Sensation; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 19683734 ↗MalfunctionOct 19, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem
IT WAS REPORTED BY THE NURSE THAT BLACK, HARD SPOTS WERE NOTICED FOR A DRESSING WHEN IT WAS TAKEN OUT OF THE PACKAGING OF FIVE. CUSTOMER CONFIRMED THAT THE PACKAGE WAS SEALED UPON RECEIPT. THE DRESSING WAS NOT AVAILABLE TO SEND BACK AS THE COMPLAINANT HAD SENT IT TO AN INDEPENDENT TESTING FACILITY (SURGICAL MATERIALS TESTING LABORATORY - SMTL) FOR TESTING. THE PRODUCT WAS NOT USED ON THE PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17964404 ↗MalfunctionSep 8, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17709930 ↗MalfunctionSep 8, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17709929 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036936 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036928 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036926 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036924 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036923 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036922 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036921 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036920 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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