ESTEEMRecalls & reported problems across all models
Convatec, Purchasing Department · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one ESTEEM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 200
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 7
We found 52 models of ESTEEM by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 200 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Dec 11, 2025 — classified as 2 injuries, 198 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (151 reports).
7 FDA recall records name at least one of these models by its device identifier, 7 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 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.
- Jul 6, 2026Open, Classified
Urostomy Pouches may leak from cap during use.
Z-2986-2026 · Root cause: Material/Component Contamination · names 14 of these models · Recall details · FDA record ↗
- Feb 16, 2026Open, Classified
Drainable large pouch may leak due to manufacturing issue.
Z-1584-2026 · Root cause: Process control · Recall details · FDA record ↗
- Feb 16, 2026Open, Classified
Drainable large pouch may leak due to manufacturing issue.
Z-1583-2026 · Root cause: Process control · Recall details · FDA record ↗
- Feb 16, 2026Open, Classified
Drainable large pouch may leak due to manufacturing issue.
Z-1582-2026 · Root cause: Process control · Recall details · FDA record ↗
- Feb 19, 2024Open, Classified
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
Z-1350-2024 · Root cause: Under Investigation by firm · names 19 of these models · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
impaired functionality of the release liner
Z-0128-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
impaired functionality of the release liner
Z-0127-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported ESTEEM problems
Device problems
- Malposition of Device151
- Positioning Problem37
- Sharp Edges19
- Complete Blockage15
- Melted15
- Material Disintegration8
- Material Too Rigid or Stiff6
- Material Protrusion/Extrusion4
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- No Consequences Or Impact To Patient66
- No Patient Involvement29
- Pressure Sore/Ulcer10
- Hemorrhage/Blood Loss/Bleeding3
- Discomfort1
- Distress1
- Embolism/Embolus1
ESTEEM models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ESTEEM 423643Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423653Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM 423657Bag, drainage, with adhesive, ostomy2 recalls0 reports
- ESTEEM+ 416740Bag, drainage, with adhesive, ostomy55 reports
- ESTEEM 423646Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423665Bag, drainage, with adhesive, ostomy1 recall1 report
- ESTEEM 423727BAG, URINARY, ILEOSTOMY1 recall1 report
- ESTEEM+ 416975Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM+ 416976Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423644Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423647Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423648Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423651Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423652Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423654Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423656Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423658Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423659Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423660Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423661Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423664Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423666Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423667Bag, drainage, with adhesive, ostomy1 recall0 reports
- ESTEEM 423704BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423705BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423712BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423713BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423714BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423715BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423716BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423717BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423718BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423722BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423723BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423725BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423726BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM+ 416747Bag, drainage, with adhesive, ostomy35 reports
- ESTEEM+ 416751Bag, drainage, with adhesive, ostomy20 reports
- ESTEEM 421631BAG, URINARY, ILEOSTOMY15 reports
- ESTEEM+ 416742Bag, drainage, with adhesive, ostomy14 reports
- ESTEEM+ 416749Bag, drainage, with adhesive, ostomy10 reports
- ESTEEM+ 413522Bag, drainage, with adhesive, ostomy10 reports
- ESTEEM+ 421617Bag, drainage, with adhesive, ostomy10 reports
- ESTEEM+ 413521Bag, drainage, with adhesive, ostomy9 reports
- ESTEEM+ 421626BAG, URINARY, ILEOSTOMY7 reports
- ESTEEM+ 422545Bag, drainage, with adhesive, ostomy4 reports
- ESTEEM+ 413515Bag, drainage, with adhesive, ostomy3 reports
- ESTEEM+ 416744Bag, drainage, with adhesive, ostomy1 report
- ESTEEM+ 416750Bag, drainage, with adhesive, ostomy1 report
- ESTEEM+ 421622Bag, drainage, with adhesive, ostomy1 report
- ESTEEM+ 422546Bag, drainage, with adhesive, ostomy1 report
- ESTEEM 423690Pouch, colostomy1 report
Recent ESTEEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 23777084 ↗MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff
THE END USER¿S FAMILY OR FRIEND REPORTED THAT FIVE OUT OF TEN MOLDABLE DISCS WERE DRIED OUT, BRITTLE AND WERE HARD TO MOLD TO APPLY AND BROKE OFF WITH REMOVAL. ALSO, HE STATED THAT ONCE APPLIED IT LEAKED WITHIN TWELVE TO TWENTY-FOUR HOURS AND AS THEY WERE TRYING TO REMOVE, THE MOLDABLE DISC WAS BREAKING OFF IN PIECES WITH SOME REMAINING STUCK TO THEIR SKIN. THE PRODUCT WAS USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690213 ↗MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff
THE END USER¿S FAMILY OR FRIEND REPORTED THAT FIVE OUT OF TEN MOLDABLE DISCS WERE DRIED OUT, BRITTLE AND WERE HARD TO MOLD TO APPLY AND BROKE OFF WITH REMOVAL. ALSO, HE STATED THAT ONCE APPLIED IT LEAKED WITHIN TWELVE TO TWENTY-FOUR HOURS AND AS THEY WERE TRYING TO REMOVE, THE MOLDABLE DISC WAS BREAKING OFF IN PIECES WITH SOME REMAINING STUCK TO THEIR SKIN. THE PRODUCT WAS USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690212 ↗MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690211 ↗MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690210 ↗MalfunctionDec 2, 2025Material Disintegration; Material Too Rigid or Stiff; Material Disintegration; Material Too Rigid or Stiff
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690208 ↗MalfunctionJul 29, 2025Sharp Edges; Sharp Edges
THE CUSTOMER REPORTED BLEEDING FROM THE STOMA THAT POOLED IN THE POUCH AND TURNED THE URINE RED. HE MENTIONED THAT THE NURSE HAD CUT THE POUCH TO THE LAST LINE, AND UPON APPLICATION, IT FELT SHARP, ALTHOUGH NO EXPOSED PLASTIC WAS SEEN. THERE WAS NO VISIBLE LACERATION ON THE STOMA, AND THE BLEEDING HAD RESOLVED. THE CUSTOMER DID NOT RECALL ANY TRAUMA OR INCIDENT THAT COULD HAVE CAUSED THE BLEEDING. NO PHOTO WAS AVAILABLE. THE INCIDENT DID NOT REQUIRE HOSPITALIZATION OR PRESCRIPTION MEDICATION, AND THE PATIENT CONTINUED USING THE PRODUCT. THE EVENT RESULTED IN BLEEDING BUT NO TISSUE DAMAGE OR SKIN IRRITATION. THE PATIENT HAS A UROSTOMY, AND NO LAB RESULTS OR CURRENT MEDICATIONS WERE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22641280 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431366 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431365 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431364 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431361 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431321 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431317 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431316 ↗MalfunctionFeb 21, 2025Sharp Edges; Sharp Edges
THE END USER REPORTED TO THE DISTRIBUTOR VIA ELECTRONIC MAIL (EMAIL) THAT THE EDGES OF VELCRO STRIPS WERE JAGGED AND NOT SMOOTH CAUSING THE LEG SORE WHEN WORN THEM. THE END USER MENTIONED THAT IT APPEARED AS THOUGH THE VELCRO STRIPS HAD BEEN CUT OUT WITH SCISSORS. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.
Patient problems: Pressure Sore/Ulcer
MAUDE report 21431315 ↗
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
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
- ESTEEM SYNERGY9 models · 241 reports · 1 recall
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.
How reports and recalls are matched · Editorial policy · Report an error on this page