AVANOS 40-9432Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770460482), received between Jun 19, 2025 and Jul 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Break; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060535 ↗
• MalfunctionApr 22, 2026Material Puncture/Hole

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. IT WAS REPORTED THE CORFLO NGT HAS A HOLE IN TUBING AND Y-ADAPTER COMING OFF. THE TUBE WAS PLACED (B)(6) 2026, AND I HAD TO PULL IT ON THE (B)(6) 2026 AS THE PATIENT COULD INSTANTLY TASTE FEEDS AND MEDS WITH LESS THAN A 3ML FLUSH AND IT WAS CAUSING ASPIRATION. WHEN PULLED THE CLINICIAN FOUND A HOLE IN IT. THE CLINICIAN REPORTS FOLLOWING PROTOCOL FROM PUBLIC HOSPITAL DIETITIAN WHICH IS MAX REPLACEMENT TIME OF 90-DAYS. ONCE SHE THROWS IT UP ITS REPLACED WITH A NEW DEVICE. THE DEVICE IS FLUSHED EVERY 3-HOURS WHILE ON FEEDS WITH A MINIMUM 60MLS WATER, SOMETHING IS "RUN" EVERY DAY. THE DEVICE IS FLUSHED WITH 30MLS WATER BEFORE AND AFTER MEDICATIONS. ALL MEDICATIONS ARE CRUSHED FINALLY AND DISPERSED IN THE PROPER AMOUNT OF WATER ACCORDING TO THE PHARMACY. THERE WERE NO REPORTED INJURIES. THE MEDICAL TREATMENT WAS TUBE REPLACEMENT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24958618 ↗
• MalfunctionApr 22, 2026Disconnection

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00250 FOR THE SECOND EVENT. IT WAS REPORTED THE CORFLO NGT HAS A HOLE IN TUBING AND Y-ADAPTER COMING OFF. THE DEVICE WAS PLACED (B)(6) AND THE MONDAY, (B)(6) 2026 THE CLEAR AND PURPLE ENFIT END CAME OFF. THE PATIENT HAD NOTICED THE DAY BEFORE SOME WATER AROUND THE CONNECTION SITE BUT ASSUMED SHE HAD GOTTEN SOME WATER ON IT EXTERNALLY. THE CLINICIAN REPORTS FOLLOWING PROTOCOL FROM PUBLIC HOSPITAL DIETITIAN WHICH IS MAX REPLACEMENT TIME OF 90-DAYS. ONCE SHE THROWS IT UP ITS REPLACED WITH A NEW DEVICE. THE DEVICE IS FLUSHED EVERY 3-HOURS WHILE ON FEEDS WITH A MINIMUM 60MLS WATER, SOMETHING IS "RUN" EVERY DAY. THE DEVICE IS FLUSHED WITH 30MLS WATER BEFORE AND AFTER MEDICATIONS. ALL MEDICATIONS ARE CRUSHED FINALLY AND DISPERSED IN THE PROPER AMOUNT OF WATER ACCORDING TO THE PHARMACY. THERE WERE NO REPORTED INJURIES. THE MEDICAL TREATMENT WAS TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958614 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED "PATIENT FEEDING TUBE WAS CLOGGED, RN [REGISTERED NURSE] FOLLOWED UNCLOGGING PROCEDURES. WHEN RN WENT TO FLUSH TO RESTART FEEDING TUBE IT WAS NOTED THE FLUSHING FLUID COMING OUT OF PATIENT MOUTH. WHEN FEEDING TUBE REMOVED ONLY A SMALL PORTION OR ABOUT 10 CM CAME OUT, THE END HAD THE APPEARANCE OF A BURST TUBE WITH A SIGNIFICANT AMOUNT WAS REMAINING INSIDE PATIENT. THE PATIENT REQUIRED 2 CHEST X-RAYS AND THEN REMOVAL OF THE FEEDING TUBE BY USING FORCEPS TO GRAB THE TUBE. NO FURTHER PATIENT HARM REPORTED. " ADDITIONAL INFORMATION RECEIVED 29-MAY-2025 STATED THE DEVICE WAS INSERTED (B)(6) 2025 AND WAS REMOVED FOLLOWING THIS INCIDENT ON (B)(6) 2025. THERE WAS NO DIFFICULTY NOTED DURING INSERTION OF THE DEVICE. THE FEEDINGS WERE CONTINUOUS. THE FEEDINGS WERE PAUSED FOR THREE WEEKS FOR DIALYSIS APPOINTMENTS, APPROXIMATELY, 4-HOURS EACH TIME. THE FEEDING SOLUTION WAS NOVASOURCE RENAL SOLUTION. THE DEVICE WAS USED FOR CRUSHED ORAL AND LIQUID MEDICATION ADMINISTRATION FREQUENTLY. THE TUBE WAS FLUSHED WITH 30ML OF WATER EVERY 4-HOURS, AS WELL AS BEFORE AND AFTER ANY MEDICATIONS WERE INSTILLED. THE TUBE WAS FLUSHED MANUALLY WITH A SYRINGE. THE SYRINGE SIZES USED FOR FLUSHING W

  Patient problems: Foreign Body In Patient

  MAUDE report 22292939 ↗