ACTIVELIFE 650832Recalls & reported problems
Convatec, Purchasing Department · Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1 1/4" (32 Mm) · Class 1
All models of ACTIVELIFE (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Activelife one-piece urostomy pouch has 26 adverse event reports, with no deaths and no injuries. The reports mostly describe pouches whose pre-cut stoma opening was off-center or the wrong size, meaning the hole did not fit the user's stoma. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00768455106653), received between Mar 6, 2019 and Oct 25, 2024 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (26 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, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device26
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THREE APPLIANCES FROM A SAMPLE PACKAGE OF THREE HAD STARTER HOLE OFF CENTERED AND WRONG SIZE PRE-CUT STOMA OPENING. HE ALSO REPORTED THAT THE STOMA OPENING ON THE PRODUCT MEASURED TO BE 1 1/8"(TWENTY NINE MILLIMETER) WHEN IT SHOULD BE 1 1/4". THE END USER WAS MEASURING ON THE ADHESIVE SIDE OF THE MASS. PHOTOS SHOWED A COMPARISON OF HIS CURRENT PRODUCT WITH THE CORRECT SIZE STOMA OPENING OF 1 1/4"(THIRTY TWO MILLIMETER) COMPARED WITH THE SMALLER PRE-CUT OPENING OF THE SAMPLES WHICH HE STATED MEASURED 1 1/8". HE ALSO STATED THAT HE WOULD LIKE TO BE ABLE TO USE A PRE-CUT ONE-PIECE SYSTEM VERSUS A TWO-PIECE SYSTEM BUT THE STOMA OPENING IS ALWAYS SMALLER THAN WHAT IT SHOULD BE. 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 20531558 ↗MalfunctionOct 25, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531557 ↗MalfunctionOct 25, 2024Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THREE APPLIANCES FROM A SAMPLE PACKAGE OF THREE HAD STARTER HOLE OFF CENTERED AND WRONG SIZE PRE-CUT STOMA OPENING. HE ALSO REPORTED THAT THE STOMA OPENING ON THE PRODUCT MEASURED TO BE 1 1/8"(TWENTY NINE MILLIMETER) WHEN IT SHOULD BE 1 1/4". THE END USER WAS MEASURING ON THE ADHESIVE SIDE OF THE MASS. PHOTOS SHOWED A COMPARISON OF HIS CURRENT PRODUCT WITH THE CORRECT SIZE STOMA OPENING OF 1 1/4"(THIRTY TWO MILLIMETER) COMPARED WITH THE SMALLER PRE-CUT OPENING OF THE SAMPLES WHICH HE STATED MEASURED 1 1/8". HE ALSO STATED THAT HE WOULD LIKE TO BE ABLE TO USE A PRE-CUT ONE-PIECE SYSTEM VERSUS A TWO-PIECE SYSTEM BUT THE STOMA OPENING IS ALWAYS SMALLER THAN WHAT IT SHOULD BE. 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 20531555 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
THE END USER REPORTED THAT TEN APPLIANCES FROM ONE MARKET UNIT HAD STARTER HOLE OFF CENTERED AS THE PRODUCT WAS NOT CUT TO CORRECT SIZE ALL THE WAY AROUND THE WAFER. ALSO, THE WAFER BODY SIDE APPEARED SMALLER THAN THE NON-BODY SIDE. THE DEVICE USED TO CUT THE WAFER DID NOT CUT THE WAFER IN CORRECT WAY WHICH MADE ITS OPENING TOO SMALL. THE END USER STOMA SIZE WAS NOT CHANGED BECAUSE HE WAS ORDERING A DIFFERENT PRECUT PRODUCT THAT WAS PRECUT TO THE SAME SIZE OF THIRTY TWO MILLIMETER (MM), THAT DID NOT HAVE THIS APPEARANCE AND FITS HIM CORRECTLY. 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 20209422 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209421 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209416 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209415 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209414 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209413 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
THE END USER REPORTED THAT TEN APPLIANCES FROM ONE MARKET UNIT HAD STARTER HOLE OFF CENTERED AS THE PRODUCT WAS NOT CUT TO CORRECT SIZE ALL THE WAY AROUND THE WAFER. ALSO, THE WAFER BODY SIDE APPEARED SMALLER THAN THE NON-BODY SIDE. THE DEVICE USED TO CUT THE WAFER DID NOT CUT THE WAFER IN CORRECT WAY WHICH MADE ITS OPENING TOO SMALL. THE END USER STOMA SIZE WAS NOT CHANGED BECAUSE HE WAS ORDERING A DIFFERENT PRECUT PRODUCT THAT WAS PRECUT TO THE SAME SIZE OF THIRTY TWO MILLIMETER (MM), THAT DID NOT HAVE THIS APPEARANCE AND FITS HIM CORRECTLY. 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 20209412 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209392 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209391 ↗MalfunctionSep 13, 2024Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209389 ↗MalfunctionSep 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED POUCH STARTER HOLE WAS OFF CENTER. THE PRODUCT WAS NOT USED ON OR BY A PATIENT. NO PHOTOGRAPHS WERE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9034083 ↗MalfunctionSep 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED POUCH STARTER HOLE WAS OFF CENTER. THE PRODUCT WAS NOT USED ON OR BY A PATIENT. NO PHOTOGRAPHS WERE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9033754 ↗MalfunctionSep 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED POUCH STARTER HOLE WAS OFF CENTER. THE PRODUCT WAS NOT USED ON OR BY A PATIENT. NO PHOTOGRAPHS WERE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9033604 ↗MalfunctionSep 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED POUCH STARTER HOLE WAS OFF CENTER. THE PRODUCT WAS NOT USED ON OR BY A PATIENT. NO PHOTOGRAPHS WERE PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9033463 ↗MalfunctionJun 7, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8680010 ↗MalfunctionJun 7, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8680005 ↗MalfunctionJun 7, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8679960 ↗MalfunctionJun 7, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8679955 ↗MalfunctionMar 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394915 ↗MalfunctionMar 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394630 ↗MalfunctionMar 6, 2019Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394592 ↗MalfunctionMar 6, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN FIVE WAFERS. NO PHOTO PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394589 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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