AVANOS 40-9431Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00350770460468), received between Sep 15, 2021 and Jul 27, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042720 ↗
• MalfunctionMay 13, 2026Fracture; Leak/Splash

  IT WAS REPORTED THAT A FEEDING TUBE HAD MULTIPLE CRACKS NEAR THE DISTAL END, RESULTING IN LEAKAGE OF BILE FROM THE TUBE EXTERNAL TO THE PATIENT AND REQUIRING REPLACEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161705 ↗
• MalfunctionFeb 18, 2026Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MDR REPORT KEY (B)(4) THE FOLLOWING INFORMATION: "ON [REDACTED DATE] AN ENTEROFLEX NASOGASTRIC WAS PLACED. PLACEMENT WAS CONFIRMED VIA X-RAY. AN ORDER WAS PLACED THAT THE LINE WAS OKAY TO USE. THE NASOGASTRIC TUBE (NGT) WAS USED TO ADMINISTER ENTERAL FEEDINGS AS WELL AS MEDICATIONS. ON [REDACTED DATE] UPON TRANSFER OF THE PATIENT TO THE INTENSIVE CARE UNIT, IT WAS DISCOVERED THAT THE INNER STYLET WAS STILL IN PLACE IN THE NASOGASTRIC TUBE. PLACEMENT WAS CONFIRMED AGAIN VIA X-RAY, AND THE INNER STYLET WAS REMOVED WITHOUT DIFFICULTY. THE CONCERN WE WOULD LIKE TO VOICE IS WITH THE DESIGN OF THE TUBE. THE INNER STYLET IS THE SAME COLOR AS THE REST OF THE VISIBLE TUBE ITSELF, SO THERE IS NO VISUAL INDICATOR THE STYLET NEEDS TO BE REMOVED. IT ALSO ALLOWS FOR ENTERAL FEEDINGS AND MEDICATIONS TO BE ADMINISTERED FREELY WITHOUT DIFFICULTY." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380524 ↗
• MalfunctionFeb 10, 2026Material Puncture/Hole

  IT WAS REPORTED, PATIENT HAD DOBHOFF INSERTED WHEN PATIENT'S RN WENT TO CONNECT TUBE FEEDS, THE DOBHOFF HAD A SMALL HOLE IN THE OUTSIDE OF THE PATIENT'S NOSTRIL. TUBE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310726 ↗
• MalfunctionMay 7, 2025Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn

  IT WAS REPORTED, ¿INFORMED BY TEAM THAT THE DHT [DOBHOFF TUBE] HAD AN ABNORMAL READING FROM THE MORNING CHEST X-RAY, REASSESSED WITH ANOTHER RAY. INSTRUCTED BY TEAM TO REMOVE DEVICE, DEVICE REMOVED WHOLE AND SAVED FOR FURTHER INSPECTION, CHARGE NURSE, TEAM AND UNIT EDUCATOR NOTIFIED. X-RAY APPEARED TO HAVE DISCONTINUITY IN FEEDING TUBE, WITH IRREGULAR OUTPOUCHING OF TUBE. ONCE REMOVED DHT WAS FOUND TO HAVE A HOLE. CLINICAL NURSE SPECIALIST [CNS] INTERVIEWED REGISTERED NURSE [RN], NO SMALL GAUGE SYRINGES USED FOR FLUSHING, NO CLOGGING NOTED, DHT FLUSHED EASILY. PATIENT WAS RECEIVING LARGE QUANTITIES OF MEDICATIONS, PROTEIN AND FLUSHES ALONG WITH TUBE FEEDING VIA DHT.¿ THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978829 ↗
• MalfunctionFeb 4, 2025Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  IT WAS REPORTED, ¿DOBHOFF TUBE REQUIRED DE-CLOGGING BETWEEN 5A-6A, LIPASE WAS USED AND THE NURSE WAS ABLE TO DE-CLOG, HOWEVER WHEN SHE WAS FINISHING DE-CLOGGING, SHE NOTED HER NEXT FLUSH WAS VERY DIFFICULT AND SHE WAS CONCERNED THAT THE DOBHOFF TUBE WAS DISPLACED. SO, I ORDERED AN ABDOMINAL X-RAY FOR CONFIRMATION. ABDOMINAL X-RAY REVEALED THAT THE DOBHOFF TUBE WAS FRACTURED IN THE STOMACH AT ABOUT 35 CM ABOVE THE BOTTOM TIP. I REMOVED THE DOBHOFF TUBE PER GASTROINTESTINAL (GI) RECOMMENDATIONS AND WAS ABLE TO RETRIEVE THE ENTIRE TUBE. THE FRACTURE WAS TO THE INTERNAL PORTION OF THE TUBE MAKING IT UNUSABLE, HOWEVER A PORTION OF THE OUTER TUBE (THE FLEXIBLE COVERING) WAS STILL INTACT AND DISTORTED, PRESUMABLY DUE TO EXPANSION DURING FLUSHING.¿ NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306099 ↗
• InjuryApr 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED VIA MEDWATCH UF REPORT (B)(4), ¿THE HOSPITAL RECENTLY BEGAN USING AVANOS NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTOR. THIS BRAND OF DOBHOFF TUBE IS A NEWER PRODUCT FOR US. THE DESIGN OF THIS PRODUCT INCLUDES TWO LUMENS, THEREFORE ALLOWING TUBE FEEDS TO BE ADMINISTERED WITH THE GUIDEWIRE IN PLACE. THE PREVIOUS NASOGASTRIC TUBE USED BY THE HOSPITAL HAD A SINGLE LUMEN, AND THEREFORE IT WAS NOT POSSIBLE TO ADMINISTER TUBE FEEDS WITH THE GUIDEWIRE IN PLACE. THE HOSPITAL HAS HAD SOME ADVERSE AND NEAR-MISS EVENTS INVOLVING WHERE TUBE FEEDS WERE ADMINISTERED OR NEARLY ADMINISTERED WITH THE GUIDEWIRE STILL IN PLACE. WE HAVE COMMUNICATED WITH THE MANUFACTURER REGARDING THIS ISSUE. WE SUGGESTED THE PRODUCT INCLUDE A VISUAL CUE ON THE OUTSIDE OF THE TUBING TO INDICATE THAT THE GUIDEWIRE IS IN PLACE. WE ALSO RECOMMENDED THAT THE MANUFACTURER ADD A VISUAL CUE ON THE PROXIMAL END OF THE GUIDEWIRE TO STATE ¿REMOVE BEFORE FEEDING.¿¿ PER ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2024, ¿THE REPORT WAS INTENDED TO ALERT YOU TO WHAT WE BELIEVE TO BE A PRODUCT DESIGN DEFECT. BECAUSE THE SIDE PORT CAN BE USED FOR FEEDS, IT HAS CREATED A FALSE SENSE OF READINESS TO USE IF THE NURSE IS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020797 ↗
• MalfunctionMay 15, 2023Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) REPORTED, ¿CORFLO¿ NASOGASTRIC/NASOINTESTINAL FEEDING TUBE IN THE STOMACH WITH IRREGULARITY AND POSSIBLE DISCONTINUITY HIGHLY CONCERNING FOR TUBE FRACTURE (COMPLETE VERSUS PARTIAL).¿ NO INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 19APR2023 REPORTED, THE RADIOLOGIST READING OF THE X-RAY REPORTED A SLIGHT OPENING ON THE LEFT-SIDE OF THE TUBE. THE TUBE WAS REMOVED IN ONE PIECE, BY INTERVENTIONAL RADIOLOGY (IR) DUE TO THE PATIENT BEING A DIFFICULT PLACEMENT FOR BEDSIDE DOBHOFF TUBE (DHT) PLACEMENT. THERE WAS NO PATIENT INJURY; HOWEVER, THE FRAIL ELDERLY PATIENT HAD TO GO TWO DAYS WITHOUT NUTRITIONAL TUBE FEED SUPPORT, IV FLUIDS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933642 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT THE END OF THE NASOGASTRIC (NG) TUBE BROKE OFF INSIDE THE PATIENT. THE CLINICIANS WERE ABLE TO REMOVE ALL THE PIECES OF THE BROKEN DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12477844 ↗