AVANOS 40-1368Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770459998), received between Jul 28, 2023 and Sep 18, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "PARENT REPORTED THAT PATIENT HAD REMOVED NG [NASOGASTRIC] AND STATED THERE APPEARED TO BE A DEFECTIVE AREA TO TUBE. ON INSPECTION OF 8FR NON-WEIGHTED NG TUBE, THERE WAS AN AREA ALONG THE TUBE THAT APPEARED TO BE A DEFLATED/EXPANDED AREA, OTHERWISE NG WAS INTACT FROM TIP TO WHERE MEDICATIONS WOULD BE INSERTED. WATER FLUSH PASSED THROUGH TUBE IN WHICH IT WOULD LEAK AT THE DEFECTIVE AREA WHILE ALSO REACHING THE TIP OF THE TUBE. WHEN NG WAS INSERTED, [REPORTER] WAS ABLE TO OBTAIN GASTRIC CONTENTS AND PUSH WATER THROUGH. AFTER MEDICATION WAS INSERTED TO TUBE, RESISTANCE WAS MET. FLUSHES AND MEDS WERE PUSHED THROUGH, IN WHICH RESISTANCE IMPROVED SLIGHTLY WITH EACH FLUSH. NO SIGNS OF DISTRESS FROM PATIENT WITH EACH FLUSH SUCH AS COUGHING OR VOMITING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084729 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THE CLINICIANS "WERE NOT ABLE TO GET STOMACH CONTENTS, CHECKED WITH AIR, AIR POP HEARD. RESISTANCE WITH FLUSHING NG [NASOGASTRIC]. REMOVAL OF NG COMPLETED AT 1410, BRIDAL CUT, DID NOT CUT NG TUBE. NG REMOVED WITH NO RESISTANCE, NG FOUND TO BE BROKEN AT 19CM MARK, X-RAY COMPLETED AND NOTED REST OF NG APPROXIMATELY 19 CM IN STOMACH. [PATIENT] TO BE SENT DOWN TO REMOVE SAME VIA SCOPE." THERE WAS NO SERIOUS HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23034346 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED "A CHEST [X-RAY WAS] PERFORMED ON (B)(6) 2024 AND INCIDENTAL FINDING OF THE BROKEN NG [NASOGASTRIC] TUBE. THE NG TUBE WAS REMOVED ON (B)(6) 2024 AND INTACT BUT THE TIP WAS BARLEY CONNECTED." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-MAY-2024 STATED NO MEDICAL INTERVENTION WAS REQUIRED, THE TUBE WAS IN PLACE FOR 1-DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593327 ↗
• MalfunctionJul 28, 2023Material Rupture; Stretched; Material Rupture; Stretched

  IT WAS REPORTED, THE NASOGASTRIC TUBE (NGT) WAS PLACED BY INTERVENTIONAL RADIOLOGY ON (B)(6) 2023. THE PATIENT VOMITED THE TUBE ON (B)(6) 2023, AND PART OF IT BROKE OFF IN THE PATIENT¿S STOMACH. IT WAS LEFT THERE AND ANOTHER TUBE WAS PLACED IN THE INFUSION CENTER THAT DAY. THE BROKEN PART WAS EVENTUALLY REMOVED AT A LATER DATE. PER ADDITIONAL INFORMATION RECEIVED ON 17JUL2023, IT IS UNKNOWN IF THE TUBE WAS EVER CLOGGED. ESOPHAGOGASTRODUODENOSCOPY WITH FOREIGN BODY REMOVAL WAS PERFORMED ON (B)(6) 2023. THE PATIENT RECOVERED WELL.

  Patient problems: Vomiting

  MAUDE report 17415195 ↗