AVANOS 42-9438Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770460963), received between Apr 26, 2024 and May 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A TUBE WAS INSERTED AND ITS POSITION CHECKED. THE GUIDEWIRE WAS REMOVED. FOLLOWING FLUSHING, LEAKAGE OF WATER WAS SEEN FROM THE END OF THE TUBE (CLOSE TO THE CONNECTOR). APPROXIMATELY 5-10MM FROM THE CONNECTOR THERE WAS A VISIBLE SMALL PUNCTURE (0.5MM) IN THE TUBE. THE TUBE WAS THEREFORE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154847 ↗
• MalfunctionMay 4, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE GUIDEWIRE OF THE NASOGASTRIC TUBE IS SHOWING THROUGH THE TIP. NORMALLY IT STOPS BEFORE THE TIP. NO INJURIES OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071716 ↗
• MalfunctionApr 23, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A HOLE WAS FOUND IN THE NASOGASTRIC TUBING BY THE NURSING STAFF BY THE CONNECTOR. NO MEDICAL INTERVENTION, OTHER THAN REPLACEMENT THE TUBE, WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975126 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THERE WAS A TEAR BETWEEN FROM Y-CONNECTOR AND TUBE AND NUTRITION LEAKED FROM THERE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849161 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THE "DEVICE WAS BLOCKED OVERNIGHT AND NURSING STAFF FLUSHED IN ATTEMPT TO UNBLOCK. A REPORTED 'POP' WAS FELT; HOWEVER THE NG (NASOGASTRIC) TUBE WAS REMOVED AT THE TIME WHERE THE END WAS FOUND TO BE FRAYED AND THE DISTAL 20CM OF TUBE WAS MISSING. X-RAY IMAGING CONFIRMED THE PRESENCE OF 20CM OF RETAINED DISTAL NG [NASOGASTRIC] TUBE WITHIN THE PATIENT'S STOMACH AND SMALL BOWEL. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22384202 ↗
• MalfunctionApr 11, 2025Break; Break

  IT WAS REPORTED "APPROXIMATELY 20 CM OF TUBE BECAME DETACHED AND WAS RETAINED AFTER REMOVAL. IT WAS SEEN TO BE IN THE DUODENUM ON AN ABDOMINAL CT [COMPUTED TOMOGRAPHY] SCAN." ADDITIONAL INFORMATION RECEIVED 21-MAR-2025 STATED, "THE BROKEN END OF THE TUBE WAS REMOVED VIA ENDOSCOPY."

  Patient problems: Foreign Body In Patient

  MAUDE report 21829822 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED, ¿DURING FLUSHING TUBE SPLIT AND PATIENT NEEDED TO BE SENT TO ENDOSCOPY FOR RETRIEVAL OF THE LOOSE END OF TUBE LEFT INSIDE OF PATIENT FOLLOWING SPLITTING." THE PATIENT WAS REPORTED TO BE ¿ALIVE AND WELL.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 20346383 ↗
• MalfunctionApr 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THERE WAS A LEAK FROM THE TUBE. THE TUBE WAS STARTED TO USE SINCE (B)(6) 2024. WHEN THE TUBE WAS FLUSHED ON (B)(6) 2024, A NURSE NOTICED THAT PATIENT'S NOSE WAS WET. THE NURSE CHECKED AND FOUND A TEAR ON THE TUBE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191709 ↗