AVANOS 20-9431Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770457932), received between Jun 8, 2021 and Jul 27, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJul 27, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50005258 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW UFR (B)(4) THE FOLLOWING INFORMATION: WHEN ATTEMPTING TO REPLACE CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE, REGISTERED NURSE (RN) NOTICED THE TIP HAD BROKEN OFF. UNABLE TO VISUALIZE AND PATIENT UNABLE TO VOCALIZE. NO DISTRESS NOTED. ON-CALL PHYSICIAN NOTIFIED AND ORDERED X-RAY OF SKULL AND ABDOMEN. ON-CALL RADIOLOGIST DID NOT VISUALIZE ANY FOREIGN BODIES. REMAINING DUOTUBE WITH PACKAGING REMOVED AND GIVEN TO CHARGE RN. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174833 ↗
• InjuryJun 30, 2021Fracture; Fracture

  ON (B)(6) 2021 FDA USER FACILITY REPORT MW5101759 WAS RECEIVED. THE EVENT DESCRIPTION STATES "THE PATIENT WAS INTUBATED AND PRIMARY NURSE AND I WAS INSERTING A SMALL BOWEL FEEDING TUBE. THE INITIAL TUBE HAD THE END PIECE AS I EXAMINED PRIOR TO INSERTION, AND AFTER PATIENT COUGHED, THE TUBE WAS REMOVED, AND I NOTICED THE TIP WAS MISSING. PATIENT SPO2 DROPPED, BECAME TACHYCARDIC, CALLED DR [REDACTED] WITH FEAR OF A PIECE OF THE SMALL BOWEL FEEDING TUBE WAS LODGED IN THE LUNGS. DR [REDACTED] DID A BRONCHOSCOPY AT BEDSIDE, HAD TO USE A GLIDESCOPE WITH MAGILL, FOUND THE TIP OF THE SMALL BOWEL FEEDING TUBE ON THE OUTSIDE OF THE ENDOTRACHEAL TUBE AND ABOVE VOCAL CORDS. SEVERAL ATTEMPTS WERE MADE WITH PIECE OF, AND TRAUMA TO THE NARES AND BACK OF THROAT WAS NOTED WITH BLEEDING. TUBING SET RECOVERED AND ISOLATED. VENDOR AND MANUFACTURER TO BE NOTIFIED." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Tachycardia

  MAUDE report 12096512 ↗
• InjuryJun 8, 2021Component Missing

  THE PATIENT WAS INTUBATED AND PRIMARY NURSE AND I WAS INSERTING A SMALL BOWEL FEEDING TUBE. THE INITIAL TUBE HAD THE END PIECE AS I EXAMINED PRIOR TO INSERTION, AND AFTER PATIENT COUGHED, THE TUBE WAS REMOVED, AND I NOTICED THE TIP WAS MISSING. PATIENT SPO2 DROPPED, BECAME TACHYCARDIC, CALLED DR. (B)(6) WITH FEAR OF A PIECE OF THE SMALL BOWEL FEEDING TUBE WAS LODGED IN THE LUNGS. DR. (B)(6) DID A BRONCHOSCOPY AT BEDSIDE, HAD TO USE A GLIDESCOPE WITH MAGILL, FOUND THE TIP OF THE SMALL BOWEL FEEDING TUBE ON THE OUTSIDE OF THE ENDOTRACHEAL TUBE AND ABOVE VOCAL CORDS. SEVERAL ATTEMPTS WERE MADE WITH PIECE OF, AND TRAUMA TO THE NARES AND BACK OF THROAT WAS NOTED WITH BLEEDING. TUBING SET RECOVERED AND ISOLATED. VENDOR AND MANUFACTURER TO BE NOTIFIED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Tachycardia

  MAUDE report 11965440 ↗