AVANOS 44292Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770442921), received between Feb 19, 2021 and Mar 26, 2026 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Misconnection” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Device Dislodged or Dislocated

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00144 FOR THE SECOND REPORT. IT WAS REPORTED, THE GASTROSTOMY TUBE WAS INITIALLY PLACED ON (B)(6) 2025 AND FELL OUT OF THE NEW STOMA ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698151 ↗
• MalfunctionNov 21, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A BALLOON BURST ON A FEEDING TUBE THAT WAS ONLY PLACED THREE WEEKS PRIOR. IT WAS THE FIRST TUBE AFTER SURGERY AND THSI WAS A NEW STOMA SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625001 ↗
• MalfunctionMar 2, 2023Misconnection; Misconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2023-00035 FOR THE FIRST REPORT; REFER TO 9611594-2023-00037 FOR THE THIRD REPORT. IT WAS REPORTED, THE PATIENT HAD A GASTROSTOMY ENFIT TUBE PLACED ON (B)(6) 2023; THEY ARRIVED TO INTERVENTIONAL RADIOLOGY (IR), ON (B)(6) 2023 FOR AN (UNSPECIFIED) TUBE MALFUNCTION, WHERE IT WAS NOTED THE BALLOON PORT HAD TUBE FEEDINGS INSIDE THE TUBE AND THE BALLOON HAD RUPTURED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 09FEB2023 REPORTED, THE STAFF WOULD NEED MORE EDUCATION ON HOW TO PROPERLY USE THE TUBES; THEY WERE EDUCATED MONTHS BEFORE THEY SAW THE TUBES AND IT WAS UNCLEAR IF THEY USED THE ¿CORRECT SYRINGES.¿ ADDITIONAL INFORMATION RECEIVED 24FEB2023 REPORTED, THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REPLACEMENT OF THE TUBE ON (B)(6) 2023; NO COMPLICATIONS IDENTIFIED; THEY WERE DISCHARGED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16474817 ↗
• MalfunctionMar 2, 2023Misconnection; Misconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2023-00036 FOR THE SECOND REPORT; REFER TO 9611594-2023-00037 FOR THE THIRD REPORT . IT WAS REPORTED, THE PATIENT HAD A GASTROSTOMY ENFIT TUBE PLACED ON (B)(6) 2023; THEY ARRIVED TO INTERVENTIONAL RADIOLOGY (IR), ON (B)(6) 2023 FOR AN (UNSPECIFIED) TUBE MALFUNCTION, WHERE IT WAS NOTED THE BALLOON PORT HAD TUBE FEEDINGS INSIDE THE TUBE AND THE BALLOON HAD RUPTURED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 09FEB2023 REPORTED, THE STAFF WOULD NEED MORE EDUCATION ON HOW TO PROPERLY USE THE TUBES; THEY WERE EDUCATED MONTHS BEFORE THEY SAW THE TUBES AND IT WAS UNCLEAR IF THEY USED THE ¿CORRECT SYRINGES.¿ ADDITIONAL INFORMATION RECEIVED 24FEB2023 REPORTED, THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REPLACEMENT OF THE TUBE ON (B)(6) 2023; NO COMPLICATIONS IDENTIFIED; THEY WERE DISCHARGED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473504 ↗
• MalfunctionMar 2, 2023Misconnection; Misconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2023-00035 FOR THE FIRST REPORT. REFER TO 9611594-2023-00036 FOR THE SECOND REPORT. IT WAS REPORTED, THE PATIENT HAD A GASTROSTOMY ENFIT TUBE PLACED ON (B)(6) 2023; THEY ARRIVED TO INTERVENTIONAL RADIOLOGY (IR), ON (B)(6) 2023 FOR AN (UNSPECIFIED) TUBE MALFUNCTION, WHERE IT WAS NOTED THE BALLOON PORT HAD TUBE FEEDINGS INSIDE THE TUBE AND THE BALLOON HAD RUPTURED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 09FEB2023 REPORTED, THE STAFF WOULD NEED MORE EDUCATION ON HOW TO PROPERLY USE THE TUBES; THEY WERE EDUCATED MONTHS BEFORE THEY SAW THE TUBES AND IT WAS UNCLEAR IF THEY USED THE ¿CORRECT SYRINGES.¿ ADDITIONAL INFORMATION RECEIVED 24FEB2023 REPORTED, THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REPLACEMENT OF THE TUBE ON (B)(6) 2023; NO COMPLICATIONS IDENTIFIED; THEY WERE DISCHARGED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473025 ↗
• DeathFeb 19, 2021Migration; Unintended Deflation; Migration; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2021-00025 FOR THE SECOND REPORT. REFER TO 9611594-2021-00026 FOR THE THIRD REPORT. REFER TO 9611594-2021-00027 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE PATIENT DEVELOPED PERITONITIS FOLLOWING MIGRATION OF THE FEEDING TUBE SOON AFTER PLACEMENT. THE TUBE APPEARED TO BE PIERCED, RESULTING IN DEFLATION OF THE BALLOON. THE ANCHORS SUPPORTING THE STOMA SITE ALSO BROKE. THE PATIENT WAS REFUSED FOR LAPAROTOMY SURGERY, TREATED WITH ANTIBIOTICS AND WAS TRANSFERRED TO PALLIATIVE CARE. THE PATIENT THEN PASSED AWAY. PER ADDITIONAL INFORMATION RECEIVED, THE GASTROSTOMY SURGERY TOOK PLACE ON (B)(6) 2021 IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THERE WAS NOTHING TO REPORT FOLLOWING THE PROCEDURE. THE PATIENT WAS MOVED TO THE VISCERAL SURGERY DEPARTMENT FOLLOWING THE PROCEDURE. NO INFORMATION WAS PROVIDED ON WHAT PROCEDURE, IF ANY, OCCURRED THERE. FOR THE NEXT SIX DAYS THERE WERE NO REPORTS ON THE PATIENT. ON (B)(6) 2021, THE PATIENT WAS TRANSFERRED TO PALLIATIVE CARE, AND THE

  Patient problems: Death; Peritonitis

  MAUDE report 11355230 ↗