AVANOS 40-7361Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770460291), received between May 14, 2021 and Jul 27, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006164 ↗
• MalfunctionJul 27, 2026Leak/Splash; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006163 ↗
• MalfunctionJun 18, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT AN NG TUBE HAD SMALL HOLES NEAR THE END OF THE TUBE DURING USE, RESULTING IN LEAKAGE AND REQUIRING REPLACEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25551606 ↗
• InjuryAug 22, 2024Malposition of Device; Material Twisted/Bent; Malposition of Device; Material Twisted/Bent

  IT WAS REPORTED, CORFLOW TUBE WAS PLACED, X-RAY REVEALED RIGHT LUNG PLACEMENT WITH PNEUMOTHORAX. THIS RESULTED IN THE PATIENT NEEDING A CT (COMPUTED TOMOGRAPHY) CHEST WITH CONTRAST, INTUBATION, CHEST TUBE INSERTION, AND HAD A BEDSIDE EGD (ESOPHAGOGASTRODUODENOSCOPY ) PERFORMED BY GENERAL SURGEON TO EVALUATE FOR ESOPHAGEAL PERFORATION. AN FDA MEDWATCH/ FDA USER FACILITY REPORT MW REPORT (B)(4) WAS RECEIVED 01-AUG-2024 STAING: PATIENT HAD AN ORDER FOR CORFLO 10FR KEOFEED INSERTION. 1ST ATTEMPT, CORFLO 10FR KEOFEED WAS PLACED WITHOUT ADVERSE EVENT. CHEST X-RAY CONFIRMED APPROPRIATE TIP INSERTION. STYLET WAS REMOVED, AND I WAS UNABLE TO FLUSH THE CORFLO 10FR KEOFEED TUBE. RN REMOVED THE KEOFEED TUBE, AND THE TIP OF IT WAS SEVERELY BENT/KINKED WHICH DID NOT ALLOW IT TO BE FLUSHED. A NEW CORFLO 10FR KEOFEED TUBE WAS OBTAINED AND INSERTED WITHOUT ANY ISSUES. A CHEST X-RAY WAS OBTAINED WHILE RN WAS IN MY OTHER PATIENT'S ROOM, AND UPON EXITING THE ROOM RN REVIEWED THE IMAGE ON THE COMPUTER AND NOTICED THAT IT WAS IN THE RIGHT LUNG. RN NOTIFIED MD AND REMOVED THE CORFLO 10FR KEOFEED TUBE. ADDITIONALLY, A PNEUMOTHORAX WAS PRESENT, AND THE GENERAL SURGEON MD WAS CONSULTED. THIS RESULTED IN THE

  Patient problems: Pneumothorax

  MAUDE report 20033175 ↗
• InjuryMay 14, 2021Break; Break

  IT WAS REPORTED THE PATIENT WITH A FEEDING TUBE PRESENTED TO THE EMERGENCY ROOM (ER) WITH COMPLAINTS OF PAIN IN HER CHEST WHEN ATTEMPTING TO USE HER NASOGASTRIC (NG) TUBE PLACED ON 28-MAR-2021. THE PATIENT STATED HER NG TUBE WILL NOT FLUSH, "IT APPEARED CLOGGED". UPON X-RAY, NG TUBE APPEARED TO BE IN 2 PIECES IN HER ESOPHAGUS. NG TUBE HAD TO BE REMOVED IN THE OPERATING ROOM. THE NG TUBE WAS STILL INTACT; HOWEVER, THERE APPEARED TO BE "AN AREA THAT LOOKED LIKE IT HAD BALLOONED AND ONLY A THIN SHEATH KEEPING THE NG TUBE TOGETHER." THE PATIENT DID NOT HAVE ANOTHER NG TUBE PLACED. THE PATIENT WAS DISCHARGED HOME FROM THE RECOVERY ROOM IN STABLE CONDITION. X-RAY OF INCIDENT REQUESTED.

  Patient problems: Chest Pain

  MAUDE report 11828577 ↗