ESTEEM SYNERGYRecalls & reported problems across all models
Convatec, Purchasing Department · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ESTEEM SYNERGY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 241
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 9 models of ESTEEM SYNERGY by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2018 and Jul 22, 2025 — classified as 241 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (210 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ESTEEM SYNERGY recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 29, 2024Open, Classified
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Z-0903-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported ESTEEM SYNERGY problems
Device problems
- Malposition of Device210
- Fluid/Blood Leak31
- Material Too Rigid or Stiff31
- Leak/Splash30
Patient problems
- No Consequences Or Impact To Patient129
- No Clinical Signs, Symptoms or Conditions52
- Pain36
- No Patient Involvement23
- Tissue Breakdown6
- Erythema1
- Skin Inflammation/ Irritation1
ESTEEM SYNERGY models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ESTEEM SYNERGY 411658Protector, Ostomy105 reports
- ESTEEM SYNERGY 411659Protector, Ostomy53 reports
- ESTEEM SYNERGY 405473PROTECTOR, OSTOMY1 recall0 reports
- ESTEEM SYNERGY 405479PROTECTOR, OSTOMY1 recall0 reports
- ESTEEM SYNERGY+ 416779POUCH, COLOSTOMY30 reports
- ESTEEM SYNERGY 409269PROTECTOR, OSTOMY29 reports
- ESTEEM SYNERGY 409270PROTECTOR, OSTOMY13 reports
- ESTEEM SYNERGY 405478PROTECTOR, OSTOMY6 reports
- ESTEEM SYNERGY 409268PROTECTOR, OSTOMY5 reports
Recent ESTEEM SYNERGY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563332 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563298 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETERS (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563296 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563295 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563281 ↗MalfunctionJul 22, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOLDABLE HOLE WAS OFF CENTERED PRIOR TO USE FOR SIX WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT. AS A RESULT, THE END USER FELT A PINCHING SENSATION TO HER STOMA AND NOTED AN INDENT ON THE STOMA. THE END USER STATED THAT THERE WAS NO STOMAL TRAUMA OR LACERATION, NO BLEEDING, AND NO MEDICAL INTERVENTION REQUESTED. SHE CONFIRMED THE STOMA SIZE WAS THIRTY-TWO MILLIMETER (MM). THE PRODUCT WAS USED BY PATIENT. NO PHOTOGRAPH OR ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Pain; Tissue Breakdown
MAUDE report 22563275 ↗MalfunctionDec 6, 2024Fluid/Blood Leak; Material Too Rigid or Stiff; Fluid/Blood Leak; Material Too Rigid or Stiff
THE WIFE OF END USER REPORTED THAT THE MASS WAS LESS PLIABLE PRIOR TO USE. THE END USER USED THE WAFERS AND NOTED THEY DID NOT MOLD TO FIT THE STOMA SIZE AND SHAPE AS PRECISELY COMPARED TO PREVIOUS WAFERS USED. SHE STATED AS A RESULT OF THE MASS BEING LESS PLIABLE, END USER DEVELOPED REDNESS TO THE IMMEDIATE PERISTOMAL SKIN. END USER'S WIFE, ALSO STATED THE SKIN IRRITATION WAS A RESULT OF LEAKAGE OF THE PRODUCT. USUAL WEAR TIME WAS THREE-FOUR DAYS. THE END USER USED COMPANY'S ADHESIVE REMOVER, WATER TO CLEANSE SKIN, ABSORPTIVE AND PROTECTIVE POWDER, COMPANY'S BARRIER WIPE, AND COMPANY'S BARRIER STRIPS. HE DID CONNECTS TO NIGHT DRAINAGE. WIFE REPORTED THAT SHE FIRST NOTED THIS APPROXIMATELY ONE MONTH AGO. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Erythema; Skin Inflammation/ Irritation
MAUDE report 20861579 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985955 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985951 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985948 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985946 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985910 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985907 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985906 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Leak/Splash; Malposition of Device; Fluid/Blood Leak; Leak/Splash; Malposition of Device
IT WAS REPORTED THAT THE STARTER HOLE OF THE WAFERS WAS NOT CENTERED. THE PRODUCT WAS USED AND CAUSED LEAKAGE. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15985904 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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