AVANOS 10237Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770102375), received between Dec 13, 2019 and Sep 21, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5102919 RECEIVED ON 24-AUG-2021 THE FOLLOWING INFORMATION: "UPON VISUAL INSPECTION DETECTION OF 1 BROKEN T-FASTENERS AND 2 MISSING T-FASTENERS FROM G-TUBE." ADDITIONAL INFORMATION RECEIVED "26-AUG-202" STATED THE PATIENT EXPERIENCE SEPSIS SECONDARY TO APPROXIMATELY 3-LITERS OF TUBE FEEDING ENTERING THE PERITONEUM. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR LAPAROTOMY, WITH WASHOUT AND A NEW GASTROSTOMY TUBE WAS INSERTED. THE PATIENT WAS STARTED ON A COURSE OF INTRAVENOUS IV ANTIBIOTICS. THE PATIENT CONTINUES TO RECOVER IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Sepsis

  MAUDE report 12510493 ↗
• InjuryAug 24, 2021Break; Break

  IT WAS REPORTED THE T-FASTENERS WERE BROKEN AND MISSING CAUSING THE PATIENT PERITONITIS DUE TO TUBE MIGRATION WHILE BEING HOSPITALIZED FOR MULTISYSTEM TRAUMA RECEIVED FROM A PEDESTRIAN/AUTOMOBILE ACCIDENT. THE PATIENT WAS THE PEDESTRIAN INVOLVED IN THE ACCIDENT. INITIAL HOSPITALIZATION REQUIRED PATIENT ADMISSION TO THE ICU FOR TREATMENT AND INTUBATION TO MAINTAIN AIRWAY. ON (B)(6) 2021 THE PATIENT'S FEEDING TUBE WAS PLACED USING AN INTRODUCER KIT. THE "CORRECT" TUBE PLACEMENT WAS CONFIRMED VIA ESOPHAGOGASTRODUODENOSCOPY (EGD) VISUALIZATION. ON (B)(6) 2021 THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR AN EMERGENCY EXPLORATORY LAP DUE TO WORSENING CONDITION. DURING THE PROCEDURE IT WAS DISCOVERED THAT TWO T-FASTENERS WERE BROKEN AND TWO T-FASTENERS WERE MISSING CAUSING THE TUBE TO MIGRATE. THREE LITERS OF ENTERAL FEEDING SOLUTION WAS REMOVED FROM THE PATIENT'S ABDOMINAL CAVITY. THE PATIENT CURRENTLY REMAINS INTUBATED AND IN STABLE BUT CRITICAL CONDITION IN THE INTENSIVE CARE UNIT (ICU) FOR TREATMENT OF MULTISYSTEM TRAUMA CAUSED BY PEDESTRIAN/AUTOMOBILE ACCIDENT, FURTHER COMPLICATED BY THE DIAGNOSIS OF PERITONITIS. THE PATIENT'S PERITONITIS IS BEING TREATED WITH INTRAVENOUS (IV)

  Patient problems: Peritonitis

  MAUDE report 12360338 ↗
• MalfunctionDec 13, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2019-00250 FOR THE FIRST EVENT. REFER TO 9611594-2019-00251 FOR THE SECOND EVENT. IT WAS REPORTED THE TRANS ABDOMINAL BOLSTERS ARE FALLING OFF CAUSING THE FEEDING TUBE TO BECOME DISLODGED AND LEAK. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 21-NOV-2019 STATED THAT SOME HAVE FALLEN OFF WITH-IN DAYS OF INSERTION. THE PHYSICIAN NOTES THERE HAVE BEEN LEAST THREE INCIDENCES OF THE BOLSTERS FALLING OFF PRIOR TO THE 2-WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470307 ↗
• MalfunctionDec 13, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2019-00250 FOR THE FIRST EVENT. REFER TO 9611594-2019-00252 FOR THE THIRD EVENT. IT WAS REPORTED THE TRANS ABDOMINAL BOLSTERS ARE FALLING OFF CAUSING THE FEEDING TUBE TO BECOME DISLODGED AND LEAK. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 21-NOV-2019 STATED THAT SOME HAVE FALLEN OFF WITH-IN DAYS OF INSERTION. THE PHYSICIAN NOTES THERE HAVE BEEN LEAST THREE INCIDENCES OF THE BOLSTERS FALLING OFF PRIOR TO THE 2-WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470305 ↗
• MalfunctionDec 13, 2019Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2019-00251 FOR THE SECOND EVENT. REFER TO 9611594-2019-00252 FOR THE THIRD EVENT. IT WAS REPORTED THE TRANS ABDOMINAL BOLSTERS ARE FALLING OFF CAUSING THE FEEDING TUBE TO BECOME DISLODGED AND LEAK. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 21-NOV-2019 STATED THAT SOME HAVE FALLEN OFF WITH-IN DAYS OF INSERTION. THE PHYSICIAN NOTES THERE HAVE BEEN LEAST THREE INCIDENCES OF THE BOLSTERS FALLING OFF PRIOR TO THE 2-WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470300 ↗