AVANOS 42-9225Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00350770460857), received between Mar 28, 2023 and Jul 8, 2026 — classified as 1 injury, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753685 ↗
• MalfunctionJun 29, 2026Material Split, Cut or Torn

  THERE WAS A TEAR ON NASOGASTRIC TUBE. IT WAS FOUND AFTER INSERTING THE TUBE IN A PATIENT, SO THE TUBE WAS REPLACED FOR NEW ONE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650892 ↗
• MalfunctionMay 12, 2026Break

  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 9611594-2026-00316 FOR THE SECOND EVENT. IT WAS REPORTED VAI FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22736670 THE FOLLOWING [EVENT 1]: SINCE [DATE REDACTED] INTO [DATE REDACTED] - A PERIOD OF APPROXIMATELY 2 MONTHS, THE CICU [CORONARY INTENSIVE CARE UNIT] AND [REDACTED]HEMATOLOGY-ONCOLOGY DEPARTMENTS HAVE NOTED 4 INCIDENTS INVOLVING THE 5FR CORPAK FEEDING TUBES. NO PATIENT HARM OR INJURY SUSTAINED BY ANY OF THE PATIENTS INVOLVED. ISSUES INCLUDE FEEDING TUBE NOTED TO BE TRANSECTED ON CHEST X-RAY ON A [AGE REDACTED] OLD PT. THE PROVIDER CAME TO BED SIDE AND FEEDING TUBE REMOVED WITH 10 CM RETAINED BY PT. OCCURRED WITH [AGE REDACTED] PATIENT. WHEN REMOVING PTS NG [NASOGASTRIC] TUBE (PLACED ESTIMATED 2 MONTHS AGO) RN GENTLY REMOVED TUBE (NO RESISTANCE WAS MET) AND UPON REMOVAL THE TUBE BROKE IN HALF. PT TOLERATED REMOVAL WELL. RN CONFIRMED TIP OF NG TUBE WAS PRESENT AT REMOVAL, AND THAT CONCERN IS NG TUBE WAS VERY FRAGILE AND IF IT WOULD HAVE BROKEN OFF WHILE STILL PLACED IN PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155014 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THE FEEDING TUBE WAS NOTED TO BE TRANSECTED ON THE MORNING X-RAY EXAMINATION. THE PROVIDER CAME TO THE "PATIENT'S BED SIDE" AND THE FEEDING TUBE WAS REMOVED WITH 10CM OF THE BROKEN DEVICE REMAINING INSIDE THE PATIENT. AN EGD (ESOPHAGOGASTRODUODENOSCOPY) WAS PERFORMED AT THE PATIENT'S BEDSIDE AND THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21130000 ↗
• MalfunctionAug 21, 2024Break; Obstruction of Flow; Break; Obstruction of Flow

  IT WAS REPORTED, ¿BROKEN TUBE IN THE STOMACH OF THE BABY. THE TUBE WAS PLACED WITHOUT ANY PROBLEMS. THEY ADMINISTERED A BOLUS OF WATER WITH SOME RESISTANCE AND WHEN THE TUBE WAS CONNECTED TO THE TUBE, THE PUMP DID NOT INDICATE PRESSURE.¿ THE TUBE WAS FOUND TO BE BROKEN. THE RETAINED PORTION OF THE TUBE WAS REMOVED VIA ENDOSCOPY. THE TUBE WAS IN USE FOR 15-30 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON 30JUL2024, THE PATIENT IS STABLE AND AT HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20010828 ↗
• MalfunctionMar 25, 2024Obstruction of Flow; Material Twisted/Bent; Material Split, Cut or Torn; Obstruction of Flow; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED, ON (B)(6) 2024, A NEW NASODUODENAL (ND) TUBE WAS PLACED. ON (B)(6) 2024, ND TUBE BECAME CLOGGED. ¿THE NURSING STAFF WAS UNABLE TO UNCLOG IT. THEY REMOVED THE ND TUBE TO FIND THAT IT WAS SPLIT OPEN ON THE SIDE. THE BREAK IS AT 31CM ON THE SIDE. PATIENT WAS NOT ANY MEDICATIONS THAT NEEDED TO BE CRUSHED OR CALCIUM CARBONATE. I KNOW THESE WERE MEDICATIONS WE DISCUSSED THAT COULD POTENTIALLY INCREASE RISK OF CLOGGING. NO SYRINGES OVER 20CC WERE USED FOR FLUSHING AND WAS ON CONTINUOUS FEEDS.¿ PER ADDITIONAL INFORMATION RECEIVED ON 08MAR2024, ¿THERE WAS NOT A PATIENT INJURY IN RESULT AND NO MEDICAL INTERVENTIONS WERE REQUIRED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969935 ↗
• MalfunctionFeb 5, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED 31-JAN-2024 STATING, "FACILITY STATES THEY FLUSHED TUBE REGULARLY."

  Patient problems: Foreign Body In Patient

  MAUDE report 18646920 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED, NASOGASTRIC (NG) TUBE BROKE OFF WHILE INSIDE OF THE PATIENT. THE PATIENT SNEEZED AND THE REST OF THE NG TUBE WAS ABLE TO BE RECOVERED. THE PATIENT IS STABLE, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. VISUAL CONFIRMATION NOTED THAT COMPLETE NG TUBE WAS RECOVERED. THE PATIENT WAS AT HOME WHEN THE EVENT OCCURED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17631085 ↗
• InjuryMar 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE CORPAK NASOGASTRIC (NG) FEEDING TUBE WAS REMOVED IN ORDER TO PLACE A NEW CORPAK NJ TUBE; UPON REMOVAL THE TUBE WAS FOUND PERFORATED AT THE LEVEL OF 4CM. ON AN ABDOMINAL X-RAY THE FRAGMENT WAS NOTED TO BE IN THE ABDOMEN, PAIN WAS REPORTED; HOWEVER, NO MEDICAL INTERVENTIONS REPORTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 REPORTED, THE DISTAL END PASSED ¿NATURALLY¿; THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16632622 ↗