ESTEEM+ 421617Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Flex Convex, One Piece Ostomy System, Drainable, V1 Pre-Cut, 30Mm · Class 1
All models of ESTEEM (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455143252), received between Jan 17, 2023 and Jan 17, 2023 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (10 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.
Most reported problems
Device problems
- Malposition of Device10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 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 16181840 ↗MalfunctionJan 17, 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 16181839 ↗MalfunctionJan 17, 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 16181838 ↗MalfunctionJan 17, 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 16181834 ↗MalfunctionJan 17, 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 16181833 ↗MalfunctionJan 17, 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 16181832 ↗MalfunctionJan 17, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED THAT STARTER HOLE OF TEN WAFERS WAS OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16181831 ↗MalfunctionJan 17, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED THAT STARTER HOLE OF TEN WAFERS WAS OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16181830 ↗MalfunctionJan 17, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED THAT STARTER HOLE OF TEN WAFERS WAS OFF CENTERED. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16181828 ↗MalfunctionJan 17, 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 16181827 ↗
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
- ESTEEM+ 416740Convatec, Purchasing Department · Bag, drainage, with adhesive, ostomy55 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
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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