ESTEEM+ 422545Recalls & reported problems
Convatec, Purchasing Department · Esteem®+ Soft Convex One-Piece Drainable V2 Precut 25Mm · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455165261), received between Dec 9, 2022 and Jun 26, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (4 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 Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTED HOLE. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196971 ↗MalfunctionJun 26, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTED HOLE. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196969 ↗MalfunctionJun 26, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED BY THE RETAILER THAT WAFER HAD OFF CENTERED STARTED HOLE. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196967 ↗MalfunctionDec 9, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT, THE WAFER WAS NOT CUT ENOUGH. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951576 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page