ESTEEM+ 416740Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Transparent, 7/8" (22Mm) · Class 1
Quick summary
This is a Convatec Esteem+ one-piece drainable ostomy pouch. The 55 reports mostly describe the pouch sitting in the wrong position on the body, with the starter hole off center so the pouch would not fit or seal properly. No deaths and no injuries are mentioned in any report. No recalls name this device, and no new reports have come in since the previous12-month period.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00768455112104), received between Dec 24, 2019 and Jan 27, 2023 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (55 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 Device55
- Positioning Problem32
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient12
- No Patient Involvement3
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2023Malposition 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 16252655 ↗MalfunctionJan 27, 2023Malposition 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 16252654 ↗MalfunctionJan 27, 2023Malposition 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 16252652 ↗MalfunctionJan 27, 2023Malposition 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 16252650 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252649 ↗MalfunctionJan 27, 2023Malposition 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 16252648 ↗MalfunctionJan 27, 2023Malposition 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 16252647 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252646 ↗MalfunctionJan 27, 2023Malposition 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 16252645 ↗MalfunctionJan 27, 2023Malposition 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 16252644 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252174 ↗MalfunctionJan 27, 2023Malposition 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 16252173 ↗MalfunctionJan 27, 2023Malposition 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 16252172 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252171 ↗MalfunctionJan 27, 2023Malposition 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 16252170 ↗MalfunctionJan 27, 2023Malposition 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 16252169 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252168 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252167 ↗MalfunctionJan 27, 2023Malposition of Device; Malposition of Device
THE END USER'S CAREGIVER REPORTED THAT SHE INSPECTED TWO MARKET UNITS WITH SAME LOT AND ALL TWENTY POUCHES IN THE BOXES APPEARED WITH THE STARTER HOLE OFF CENTERED. SHE DID NOT ALLOW THE END USER TO WEAR ANY OF THESE POUCHES. THE PHOTOGRAPHS WERE RECEIVED FROM THE COMPLAINANT DEPICTING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16252166 ↗MalfunctionJan 27, 2023Malposition 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 16252165 ↗MalfunctionJan 27, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251813 ↗MalfunctionJan 27, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER'S CAREGIVER REPORTED THE STARTER HOLE OF TWENTY APPLIANCES WAS OFF CENTERED. ADDITIONALLY, CAREGIVER STATED THAT FIVE POUCHES FROM THE BOX WERE WORN AND HAD FIFTEEN MORE WERE OFF CENTERED BUT NOT WORN, FROM TWO MARKET UNITS WITH SAME LOT. ADDITIONALLY, IT WAS ALSO MENTIONED THAT END USER HAD NOTICED SEVERAL WEEKS AGO THAT THE POUCHES WERE NOT STICKING TO HER SKIN, AND SHE HAD NOT CHANGED ANY PART OF HER APPLICATION ROUTINE. ALSO, HER WEAR TIME WAS REDUCED FROM THREE DAYS TO LESS THAN ONE DAY, AND SHE DENIED ANY LEAKAGE OF STOOL. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251812 ↗MalfunctionJan 27, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER'S CAREGIVER REPORTED THE STARTER HOLE OF TWENTY APPLIANCES WAS OFF CENTERED. ADDITIONALLY, CAREGIVER STATED THAT FIVE POUCHES FROM THE BOX WERE WORN AND HAD FIFTEEN MORE WERE OFF CENTERED BUT NOT WORN, FROM TWO MARKET UNITS WITH SAME LOT. ADDITIONALLY, IT WAS ALSO MENTIONED THAT END USER HAD NOTICED SEVERAL WEEKS AGO THAT THE POUCHES WERE NOT STICKING TO HER SKIN, AND SHE HAD NOT CHANGED ANY PART OF HER APPLICATION ROUTINE. ALSO, HER WEAR TIME WAS REDUCED FROM THREE DAYS TO LESS THAN ONE DAY, AND SHE DENIED ANY LEAKAGE OF STOOL. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251811 ↗MalfunctionJan 27, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251810 ↗MalfunctionJan 27, 2023Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE END USER'S CAREGIVER REPORTED THE STARTER HOLE OF TWENTY APPLIANCES WAS OFF CENTERED. ADDITIONALLY, CAREGIVER STATED THAT FIVE POUCHES FROM THE BOX WERE WORN AND HAD FIFTEEN MORE WERE OFF CENTERED BUT NOT WORN, FROM TWO MARKET UNITS WITH SAME LOT. ADDITIONALLY, IT WAS ALSO MENTIONED THAT END USER HAD NOTICED SEVERAL WEEKS AGO THAT THE POUCHES WERE NOT STICKING TO HER SKIN, AND SHE HAD NOT CHANGED ANY PART OF HER APPLICATION ROUTINE. ALSO, HER WEAR TIME WAS REDUCED FROM THREE DAYS TO LESS THAN ONE DAY, AND SHE DENIED ANY LEAKAGE OF STOOL. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251809 ↗
Other Bag, drainage, with adhesive, ostomy devices
- ESTEEM 423657Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423643Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423653Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ACTIVELIFE 022767Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy60 reports
- ACTIVELIFE 022765Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy53 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.