ACTIVELIFE 022765Recalls & reported problems
Convatec, Purchasing Department · Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape, 12" Trans, 1" (25 Mm.) · Class 1
Quick summary
This Convatec Activelife one-piece drainable ostomy pouch comes with a pre-cut opening and adhesive skin barrier. The 53 reports mostly describe the pre-cut hole being off center before use, making the pouch unusable; some mention positioning problems and user distress. No deaths or injuries are reported, and 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00768455101559), received between Oct 24, 2019 and Nov 7, 2021 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (53 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Malposition of Device53
- Positioning Problem17
Patient problems
- No Consequences Or Impact To Patient41
- Distress10
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2021Malposition of Device; Malposition of Device
THIS EMDR IS FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED WAFERS AN UNKNOWN MARKET UNIT. IT WAS REPORTED THAT SEVERAL YEARS AGO SHE NOTED THAT PRE-CUT MASS HOLE IS OFF CENTER PRIOR TO USE. SHE DID VISUALLY INSPECT THE APPLIANCES. SHE FELT THAT THIS MADE THE PRODUCT UNUSABLE. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12758496 ↗MalfunctionNov 7, 2021Malposition 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 12758480 ↗MalfunctionJun 10, 2020Malposition 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 10136997 ↗MalfunctionJun 10, 2020Malposition 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 10136995 ↗MalfunctionJun 10, 2020Malposition 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 10136994 ↗MalfunctionJun 10, 2020Malposition 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 10136964 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT 10 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD OFF CENTERED PRECUT OPENING. REPORTEDLY, 6 FROM ONE BOX AND 4 FROM THE OTHER BOX WERE AFFECTED. THE END USER EXPRESSED FRUSTRATION AND DID NOT USE THE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Distress
MAUDE report 10019956 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT 10 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD OFF CENTERED PRECUT OPENING. REPORTEDLY, 6 FROM ONE BOX AND 4 FROM THE OTHER BOX WERE AFFECTED. THE END USER EXPRESSED FRUSTRATION AND DID NOT USE THE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Distress
MAUDE report 10019953 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019952 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019951 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019950 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019949 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019948 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019947 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Distress
MAUDE report 10019946 ↗MalfunctionMay 4, 2020Malposition of Device; Malposition of Device
THE END USER STATED THAT 10 POUCHES FROM 2 MARKET UNITS WITH THE SAME LOT NUMBER HAD OFF CENTERED PRECUT OPENING. REPORTEDLY, 6 FROM ONE BOX AND 4 FROM THE OTHER BOX WERE AFFECTED. THE END USER EXPRESSED FRUSTRATION AND DID NOT USE THE PRODUCTS. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: Distress
MAUDE report 10019945 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731790 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731789 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731788 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731786 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731776 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731775 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731774 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731773 ↗MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device
THE END USER REPORTED THAT THE WAFERS HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS SO OFF-CENTERED THAT IT COULD NOT BE USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9731772 ↗
Other Bag, drainage, with adhesive, ostomy devices
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- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ACTIVELIFE 022767Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy60 reports
- ESTEEM+ 416740Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy55 reports
- ESTEEM 423646Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423665Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423647Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.