AVANOS 42731Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770427317), received between Aug 13, 2021 and Mar 17, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 17, 2026Flushing Problem; Leak/Splash

  IT WAS REPORTED, ¿THE CONSUMER REPORTS A BLOCKED BUTTON THAT NECESSITATED REPLACEMENT DURING THE NIGHT. THE CONSUMER'S BLOOD SUGAR LEVELS WERE IN THE HYPOGLYCEMIC RANGE, AND THE FEEDING PUMP CONTINUED TO OPERATE WITHOUT AN ALARM. THE FEEDING SOLUTION WAS OBSERVED TO BE LEAKING FROM THE SAFETY CONNECTOR NEXT TO THE BUTTON. BLOOD SUGAR LEVELS WERE MONITORED FROM 00:21 TO 4:57 A.M., WITH READINGS BETWEEN 28 MG AND 110 MG. AT 0:30 A.M., A 5 ML DOSE OF 40% GLUCOSE CONCENTRATE WAS ADMINISTERED ORALLY AS AN EMERGENCY MEASURE. SUBSEQUENTLY, THE CONSUMER RECEIVED HUMANA WITH RICE FLAKES VIA A NEW BUTTON AND STARCH ORALLY TO STABILIZE BLOOD SUGAR. AT 4:47 A.M., THE SAME PUMP WAS RECONNECTED AND OPERATED UNTIL 9:40 A.M. AT A RATE OF 50 ML/H. AN ATTEMPT TO FLUSH THE REMOVED, DEFECTIVE BUTTON WAS UNSUCCESSFUL. THE BUTTON WAS FLUSHED WITH WATER AFTER THE EVENING MEAL AT 6:00 P.M., AS IS CUSTOMARY, BEFORE CONNECTING THE PUMP FOR ITS SCHEDULED OVERNIGHT OPERATION. THE PUMP WILL NOT BE USED FOR THE TIME BEING, STARTING TONIGHT. THE FAMILY WILL USE A PUMP WITH SERIAL NUMBER: (B)(6). THE CONSUMER IS 2 YEARS OLD, MALE, WITH A DIAGNOSIS OF GLYCOGEN STORAGE DISEASE TYPE 1A. THE APPLICATION TECHNIQUE INV

  Patient problems: Hypoglycemia

  MAUDE report 24621318 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak; Malposition of Device

  IT WAS REPORTED THE G-TUBE INSERTED ON (B)(6) 2026. ON (B)(6) 2026, DRESSING CHANGE DUE FOR G-TUBE. DURING A DRESSING CHANGE THE G-TUBE WAS FOUND TO BE DISLODGED. THE NURSE (NP) WAS CONTACTED WHICH IS WHEN THEY INSERTED A FOLEY TEMPORARILY. AT THE TIME OF THE REPORT THE USER INSTILLED STERILE WATER INTO G-TUBE BALLOON PORT AND NOTED IT TO BE LEAKING ONTO BLUE PAD. THE NP WAS ABLE TO FIND A NEW G-TUBE AND A NEW G-TUBE WAS INSERTED WITH CAREGIVER'S CONSENT. THE PATIENT WAS SENT FOR A GASTROINTESTINAL (GI) STUDY TO CONFIRM PLACEMENT WITH CONTRAST. ONCE CONFIRMED BY RADIOLOGY THE PATIENT'S FEEDS WERE RE-STARED THROUGH NEW G-TUBE. NO PATIENT INJURY. PATIENT HAD TO HAVE A REPLACEMENT G-TUBE URGENTLY INSERTED DUE TO IMMATURE TRACT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500859 ↗
• MalfunctionMay 29, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THERE WAS A "FEEDING TUBE FAILURE; STATES THE TUBE WAS PLACED (B)(6) 2025 WITH NEW STOMA CREATION, AND ON (B)(6) 2025 THE TUBE CAME OUT OF THE STOMA SITE; PATIENT WAS TAKEN TO ER [EMERGENCY ROOM] FOR TUBE REPLACEMENT AND REQUIRED A REPEAT PROCEDURE FOR STOMA CREATION." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108720 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS STOMACH FLUID LEAKING ON PATIENT¿S SKIN DUE TO THE FAULTY BUTTON CAUSING THE PATIENT IRRITATION AND TREATMENT WAS NEEDED. SINCE THE SURGERY WAS DONE ON JANUARY 9TH IT IS STILL TOO EARLY TO TAKE OUT THE MICKEY BUTTON FROM THE PATIENT¿S INSERTION SITE. HYPERTONIC SALINE SOLUTION SOAKS WERE PERFORMED. "NOT MUCH WE CAN DO FRESHLY POST OP." THERE WAS NO REPORTED INJURY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21746243 ↗
• MalfunctionMar 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THE TUBE WAS INSERTED IN MID-(B)(6) EXACT DATE UNKNOWN. THE PATIENT PRESENTED TO THE HOSPITAL ON THE (B)(6) 2024 WITH THE BALLOON UNABLE TO BE DEFLATED THROUGH THE BALLOON PORT. THE PROVIDER TRIED TO INFLATE BUT NO SUCCESS. "TRIED TO PUSH THE BALLOON PORT IN WITH A PAPERCLIP TO RELEASE WITH NO SUCCESS. WHITE BALLOON PORT BECAME DETACHED FROM THE MIC-KEY G TUBE. CUT MIC-KEY TUBE BELOW THE LOW-PROFILE BUTTON. THE WATER WITHIN THE BALLON DID NOT APPEAR TO RELEASE AND BALLON FELL THROUGH THE STOMA. THE PATIENT HAD "MULTIPLE PRESENTATIONS WITH SEVERAL X-RAYS BUT NOTHING WAS SHOWING AND THEN DISCOVERED ON THE (B)(6) 2025 THROUGH CT [COMPUTED TOMOGRAPHY] SCAN SHOWED INFLATED GASTROSTOMY BALLOON IDENTIFIED IN ILEUM. SEROUS ASCITES EVIDENT. ON DELIVERY OF BOWEL WITH LAPAROTOMY BALLOON SLID MORE PROXIMALLY SO ENTEROTOMY WAS MADE IN JEJUNUM. PROXIMAL BOWEL DISTENDED AND HEMORRHAGIC, BUT NO ISCHEMIC BOWEL SEEN. SURGERY ON THE (B)(6) 2025 LONGITUDINAL ENTEROTOMY IN JEJUNUM AND BALLON DELIVERED, CLOSURE 4.0 PDS [POLYDIOXANONE SUTURES] INTERRUPTED TRANSVERSELY. BOWEL RETURNED TO ABDOMEN. WENT TO HDU [HIGH DEPENDENCY UNIT] POST-OP ON ANTIBIOTICS FOR 48-HOURS. NGT [NASOGASTRIC TUBE]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537328 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S STOMA SITE WAS NOT HEALING AND THEY WERE HAVING CONSTANT INFECTIONS. PER ADDITIONAL INFORMATION RECEIVED 27 JUL 2021, THE PATIENT IS A PEDIATRIC PATIENT AND IS BEING TREATED WITH ANTIBIOTICS. THE STOMA SITE WAS DESCRIBED AS "GUNKY AND NOT HEALING." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 12318137 ↗