FLEXI-SEALRecalls & reported problems across all models

We found 4 models of FLEXI-SEAL by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2017 and Feb 3, 2026 — classified as 36 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (18 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. 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

Most reported FLEXI-SEAL problems

FLEXI-SEAL models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FLEXI-SEAL 421630

  Tubes, gastrointestinal (and accessories)
  20 reports
• FLEXI-SEAL 418000

  POUCH, COLOSTOMY
  16 reports
• FLEXI-SEAL 421703

  Tubes, gastrointestinal (and accessories)
  1 report
• FLEXI-SEAL 422303

  Tubes, gastrointestinal (and accessories)
  1 report

Recent FLEXI-SEAL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026

  RN ATTEMPTED TO FLUSH WATER THROUGH RECTAL TUBE IN PREPARATION FOR MEDICATION ADMINISTRATION WHEN NOTICED BULDGING OF THE RECTAL TUBE IN VARIOUS SPOTS WITH CONCERN FOR OUTPOUCHING OF FLUID AND POTENTIAL RUPTURE. RECTAL TUBE REMOVED AND NEW RECTAL TUBE PLACED. NO KNOWN INJURY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245993 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDWATCH REPORT # (B)(4) WAS RECEIVED FROM THE FDA. IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT FOR METABOLIC ACIDOSIS AND SUBDURAL HEMATOMA. THE CIRRHOTIC PATIENT WITH A FECAL MANAGEMENT SYSTEM (BALLOON) DEVELOPED HEMORRHAGIC SHOCK REQUIRING MASSIVE TRANSFUSION PROTOCOL AND USE OF VASOPRESSORS FOR HEMODYNAMIC INSTABILITY. EGD [ESOPHAGOGASTRODUODENOSCOPY] WAS PERFORMED AT BEDSIDE AND PER DOCTOR, PT BLEEDING WAS RELATED TO FECAL CONTAINMENT DEVICE THAT CAUSE ULCERATION AND ARTERIAL BLEEDING. THE PATIENT SUBSEQUENTLY REQUIRED AN ADDITIONAL 4 UNITS PRBCS [PACKED RED BLOOD CELLS] AND UP TITRATION OF LEVOPHED FOR HEMODYNAMIC INSTABILITY POST EGD FOR CONTINUED BRBPR [BRIGHT RED BLOOD PER RECTUM]. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PHOTOS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22439046 ↗
• MalfunctionMay 17, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED AN INTENSIVE CARE PATIENT EXHIBITED MULTI-ORGAN FAILURE, AND CHRONIC DIARRHEA, WHICH JUSTIFIED FLEXI-SEAL BASED ON NURSING BENEFIT. THE PATIENT HAD A FLEXI-SEAL PROTECT IN PLACE FOR THREE WEEKS. "BLEEDING FROM THE RECTUM WAS OBSERVED, AND A RECTOSCOPY SHOWED CIRCUMFERENTIAL NECROSIS IN THE DISTAL RECTUM. THE EXAMINATION ALSO FOUND THAT THE PRODUCT WAS FILLED WITH MORE THAN 100 ML OF WATER WHEN IT SHOULD ONLY BE FILLED WITH LESS THAN OR EQUAL TO 45 ML. THE PATIENT WAS HOSPITALIZED FOR ANOTHER MONTH AND WAS THEN DISCHARGED. HOWEVER, THE PATIENT WAS READMITTED SHORTLY AFTER WITH ABDOMINAL PAIN, WHICH IS CONFIRMED TO BE DUE TO OBLITERATING SWELLING IN THE DISTAL BOWEL WHERE THE PREVIOUS INJURY WAS NOTED AND IS INTERPRETED AS A DIRECT EFFECT OF THIS. THE PATIENT GOT OPERATED AND GOT A RELIEVING SIGMOID OSTOMY." PER THE INFORMATION PROVIDED, THE PROBABLE CAUSE IS "DUE TO A MISTAKE IN USE WHERE THE FLUSHING CHANNEL WAS CONFUSED WITH THE CUFF, WHEREBY THE CUFF BALLOON WAS ENLARGED AND COULD CAUSE PRESSURE DAMAGE TO THE INTESTINE. IT IS QUITE POSSIBLE TO CONFUSE THESE AS THE SAME SYRINGE CAN BE USED WITH LUER COUPLING. THE MARKING IS PRESENT BUT NOT VERY CLEAR."

  Patient problems: Necrosis; Pain

  MAUDE report 19339686 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WE RECENTLY HAD A PATIENT WHERE THE FLEXISEAL WAS UTILIZED FROM 12/24/2023 -1/6/2024. UPON DISCONTINUATION OF THE RECTAL TUBE THE PATIENT WAS NOTED TO HAVE INFARCTED TISSUE EXTRUDING FROM THE RECTUM AND ALSO DEVELOPED A RECTOVAGINAL FISTULA." THE DEVICE WAS INSERTED (B)(6) 2023 IN A FEMALE PATIENT WITH LIQUID STOOL. NO DETAILS ABOUT INSERTION OR PATIENT INFORMATION AVAILABLE. THE DEVICE WAS REMOVED (B)(6) 2024 AS THEY WANTED TO GIVE IMODIUM AND REMOVE THE DEVICE. UPON REMOVAL THE BEDSIDE NURSE NOTED NECROTIC TISSUE EXTRUDING FROM THE RECTUM. THE NURSE REPORTED 45CC OF FLUID IN BALLOON UPON REMOVAL. THE PATIENT REQUIRED SURGERY TO REMOVE THE NECROTIC TISSUE. DURING SURGERY THE SURGEON DISCOVERED A RECTOVAGINAL FISTULA HOWEVER HE RECOMMENDED REPAIR OF THE FISTULA AT A LATER TIME. THE SURGEON CONFIRMED WITH THE PATIENT AFTER REMOVAL THAT SHE HAD NO PREEXISTING ISSUES WITH THE RECTUM.

  Patient problems: Necrosis; Tissue Breakdown

  MAUDE report 18621702 ↗
• InjuryJun 22, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED "NO PR EXAM PRIOR TO INSERTION OF FMS; PATIENT WAS RESTLESS SO THE DEVICE WAS REMOVED AFTER ONLY 7 HOURS IN SITU. AFTER 21 DAYS POST REMOVAL, THE PATIENT WAS NOTED TO BE ADMITTED WITH CIRCUMFERENTIAL RECTAL NECROSIS, SUBSEQUENTLY REQUIRING TO HAVE A PERMANENT COLOSTOMY."

  Patient problems: Necrosis

  MAUDE report 17181572 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A FULL THICKNESS PRESSURE INJURY WHEN USING THE FECAL MANAGEMENT DEVICE (FMS). FMS WAS IN PLACE (B)(6) 2022. IT WAS UNKNOWN IF A RECTAL EXAM WAS DONE PRIOR TO PLACEMENT AND UNKNOWN HOW MUCH FLUID WAS INSTILLED IN THE DEVICE. MEDICAL TREATMENT WAS PROVIDED HOWEVER TYPE OF MEDICAL TREATMENT WAS NOT PROVIDED. THE FMS DEVICE WAS DISCONTINUED. PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Tissue Breakdown

  MAUDE report 16910821 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXHIBITED A "FULL THICKNESS WOUND, INJURY IS ADHERENT SLOUCH COVERED. INJURY IS TO THE PERIRECTAL SKIN JUST INFERIOR TO THE RECTUM." IT WAS FURTHER STATED THE BAG IS USUALLY AT THE END OF THE BED. THE DEVICE WAS IN PLACE FROM APRIL 1 TO APRIL 5. THE DEVICE HAS BEEN REMOVED.

  Patient problems: Tissue Breakdown

  MAUDE report 16760737 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #13 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886079 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #12 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886036 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #14 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886035 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #7 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885991 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #11 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885988 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #6 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885986 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #5 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885983 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #4 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885981 ↗

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