AVANOS 40-9368Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00350770460437), received between Aug 28, 2023 and Jul 14, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Material Puncture/Hole

  Patient problems: Abdominal Distention

  MAUDE report 25816975 ↗
• MalfunctionJul 2, 2026Partial Blockage; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE BALLOONED DURING USE. MEDICATIONS COULD BE FLUSHED THROUGH THE TUBE; HOWEVER, WHEN SALINE WAS ADMINISTERED, THE TUBE BALLOONED AND COULD NOT BE FLUSHED FURTHER WITHOUT CONCERN THAT IT WOULD BURST. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690535 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5187615 THE FOLLOWING.: SEVERAL EVENTS OF ENFIT PORT DETACHING FROM TUBE FOR VARIOUS LOTS OF 6FR AND 8FR AVANOS CORFLO FEEDING TUBES. TUBE REPLACEMENTS REQUIRED FOR ALL PATIENTS AFFECTED. PATIENTS REQUIRED TUBE REPLACEMENT UNDER ANESTHESIA COMPLETED IN INTERVENTIONAL RADIOLOGY, ADDITIONAL EXPOSURE TO ANESTHESIA AND RADIATION TO REPLACE DEFECTIVE TUBES. IN ONE EVENT PORT DETACHED AT HOME AND PATIENT REQUIRED ADMISSION FOR CARE AND REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537008 ↗
• MalfunctionJun 4, 2026Complete Blockage; Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED "PATIENT'S NG "[NASOGASTRIC TUBE]" SLUGGISH TO FLUSH WITH INITIAL MEDS, HOWEVER, SAME ABLE TO BE INSTILLED. RN "[REGISTERED NURSE]" ATTEMPTED TO RELIEVE... OBSTRUCTION BUT STILL VERY SLUGGISH TO FLUSH. PLANNED TO REPLACE NG WHILE PATIENT SEDATED AND INTUBATED. HOWEVER, NG UNABLE TO BE REMOVED AND WAS STUCK. WHEN PATIENT WAS EXTUBATED, NG WAS ABLE TO BE REMOVED. LARGE HOLE SEEN IN MIDDLE OF TUBE. RN INSERTED NEW NG WITHOUT INCIDENT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399090 ↗
• MalfunctionJun 4, 2026Leak/Splash; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00408 FOR THE FIRST REPORT, REFER TO 9611594-2026-00409 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS A HOLE IN THE DISTAL PART OF THE NG TUBING CLOSE TO THE CONNECTION OF THE NG PUMP TUBING WHERE FORMULA WAS COMING OUT. THE HOLE CAUSED THE MEDICATION TO LEAK OUT OF THE TUBE AND PATIENT WAS UNABLE TO GET MEDICATION. THE NGT REMOVED AND THEY HAD TO REINSERT A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399018 ↗
• MalfunctionJun 4, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00408 FOR THE FIRST REPORT. REFER TO 9611594-2026-00410 FOR THE THIRD REPORT. IT WAS REPORTED THAT THERE WAS A HOLE IN THE NASOGASTRIC (NG) TUBING. THE NG TUBE WAS PERFORATED WHEN ATTEMPTING TO BEGIN THE FEED FOR THE FIRST TIME. NGT WAS REMOVED AND THEY HAD TO REINSERT A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399014 ↗
• MalfunctionJun 4, 2026Leak/Splash; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00409 FOR THE SECOND REPORT. REFER TO 9611594-2026-00410 FOR THE THIRD REPORT. IT WAS REPORTED THAT THERE WAS A HOLE IN THE DISTAL PART OF THE NASOGASTRIC (NG) TUBING CLOSE TO THE CONNECTION OF THE NG PUMP TUBING WHERE FORMULA WAS COMING OUT. THE TUBE WAS INSERTED IN THE PATIENT. THE HOLES WERE IDENTIFIED RIGHT AFTER INSERTION WHEN ATTEMPTING TO USE. THE TUBE WAS REMOVED AND THEY HAD TO REINSERT A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399007 ↗
• MalfunctionJun 2, 2026Fracture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00385 FOR THE FIRST REPORT. REFER TO 9611594-2026-00386 FOR THE SECOND REPORT. IT WAS REPORTED THAT A PEDIATRICS DEPARTMENT IS EXPERIENCING RECENT ISSUES WITH THE 8FR NG TUBES. THE TUBE TORE AS IT WAS BEING REMOVED FROM THE PATIENT. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364063 ↗
• MalfunctionJun 2, 2026Fracture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00385 FOR THE FIRST REPORT, FOR THE SECOND REPORT , REFER TO 9611594-2026-00387 FOR THE THIRD REPORT . IT WAS REPORTED THAT A PEDIATRICS DEPARTMENT IS EXPERIENCING RECENT ISSUES WITH THE 8FR NG TUBES. THE TUBE TORE AS IT WAS BEING REMOVED FROM THE PATIENT. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364058 ↗
• MalfunctionJun 2, 2026Fracture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00386 FOR THE SECOND REPORT. REFER TO 9611594-2026-00387 FOR THE THIRD REPORT. IT WAS REPORTED THAT A PEDIATRICS DEPARTMENT IS EXPERIENCING RECENT ISSUES WITH THE 8FR NG TUBES. THE TUBE TORE AS IT WAS BEING REMOVED FROM THE PATIENT. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364057 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THE NASOGASTRIC (NG) TUBE WAS PLACED AND "CONFIRMED VIA KUB. NURSE EVALUATED NG TUBE AND NOTED LEAKING FROM NG LINE NEAR THE HUB OF THE NG TUBE. NG HAD TO BE PULLED AND REPLACED." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 28-MAY-2026 STATING "THE TUBE WAS ONLY IN PLACE FOR A FEW HOURS, NO OIL-BASED PRODUCTS, ONLY FEEDS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903765 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED "THE PATIENT HAD BEEN HAVING INTERMITTENT EMESIS FOR THE PAST THREE DAYS WITH FEEDS. WHEN [THE CLINICIAN] ARRIVED FOR... SHIFT ON 25-JAN-2026 THE PATIENT THREW UP A VERY LARGE AMOUNT OF FORMULA. [THE CLINICIAN] STOPPED THE FEEDS AND GAVE HIS STOMACH A BREAK FOR ABOUT 30 MIN BEFORE GIVING MEDS. WHILE GIVING MEDS HE GAGGED AND THREW UP AFTER ONLY 1 ML BEING GIVEN. GAVE PT ZOFRAN AND TRIED AGAIN WITH WATER AND HE GAGGED AND THREW THAT UP. ATTEMPTED TO VERIFY PLACEMENT BUT WAS UNABLE TO WITH A PH AND UNABLE TO PULL BACK STOMACH CONTENTS. [THE CLINICIAN] DID NOT HEAR ANY CRACKLES OR FLUID IN THE LUNGS AS WELL. ON 24-JAN-2026 THIS HAD HAPPENED AND AFTER ALL THE SAME TROUBLE SHOOTING TECHNIQUES THE CN [CLINICAL NURSE] TOLD ME TO ASK FOR A KUB [KIDNEY, URETERS AND BLADDER]. DUE TO THIS HAPPENING AGAIN ON 1/25 I ASKED FOR A KUB AGAIN AFTER GOING THROUGH THE SAME TROUBLE SHOOTING. TUBE WAS IN THE RIGHT PLACE BASED ON THE KUB ON BOTH DAYS BUT PT NAUSEA WAS MUCH WORSE ON 25-JAN-2026. AFTER REACHING OUT TO THE TEAM I WAS INSTRUCTED TO PUSH MEDS SLOWER TO AVOID EMESIS. PUSHING 3 MEDS THROUGH THE TUBE TOOK AN HOUR AND THE PT THREW THEM UP AT THE END. PUSHED THE REST OF THE MEDS SL

  Patient problems: Vomiting

  MAUDE report 24461208 ↗
• MalfunctionFeb 26, 2026Break; Component Missing

  IT WAS REPORTED THE PATIENT "ACCIDENTALLY REMOVED HIS NG [NASOGASTRIC] TUBE, AND THE CATHETER WAS NOT INTACT. UPON MEASURING, IT WAS 2.5 CM SHORTER THAN WHAT IT SHOULD HAVE BEEN." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461180 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED, "PRIOR TO NASOGASTRIC PLACEMENT, OUR STANDARD PROCESS WAS FOLLOWED: THE STYLET WAS TESTED, THE TUBE WAS INSPECTED FOR ANY VISIBLE DEFECTS, AND THE EVL WAS MEASURED. THE PLACEMENT WAS COMPLETED WITHOUT DIFFICULTY. HOWEVER, WHEN ATTEMPTING TO ASPIRATE GASTRIC CONTENTS FOR PH TESTING, GASTRIC FLUID BEGAN LEAKING FROM A PINPOINT HOLE LOCATED JUST BELOW THE PLASTIC ADAPTER AT THE END OF THE TUBE." PER ADDITIONAL INFORMATION RECEIVED ON 03FEB2026, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24420326 ↗
• MalfunctionFeb 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED, ¿NGT (NASOGASTRIC TUBE) REMOVED AND END WAS SPLAYED/SPLIT AND NOTED TO BE MISSING 8 CM OF TUBE. TUBE HAD SEPARATED AND (KIDNEYS, URETERS, AND BLADDER) KUB ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367287 ↗
• MalfunctionJan 29, 2026Leak/Splash

  IT WAS REPORTED, TUBE LEAKED NEAR HUB / END OF TUBE WITHIN 24 HOURS OF ADMISSION. NASOGASTRIC (NG) TUBE DISCONTINUED ON DAY SHIFT. PATIENT WAS ABLE TO AVOID THE NEED OF A FURTHER NG. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 24211683 ↗
• MalfunctionJan 21, 2026Complete Blockage

  IT WAS REPORTED THE "PATIENT HAD A AVANOS CORFLO NASOGASTRIC FEEDING TUBE INSERTED IN HIS LEFT NARE. FEEDING PUMP WAS ALERTING OF ON OCCLUSION. NURSE CHECKED FOR KINKS AND DID NOT FIND ANY, AFTER RESTARTING FEEDS THE PUMP ALERTED FOR OCCLUSION AGAIN. FEEDING PUMP WAS STOPPED AND NURSE FLUSHED THE TUB WITH 2ML OF WATER, WHILE FLUSHING NURSE NOTICED A BULGE IN THE TUBE THAT WAS CAUSING OBSTRUCTION." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132634 ↗
• MalfunctionJan 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED, MOM REPLACED PATIENT¿S NASOGASTRIC TUBE. ONLY AIR COULD BE ASPIRATED. HOLE NOTED NEAR FEEDING PORT.

  Patient problems: Insufficient Information

  MAUDE report 24053951 ↗
• MalfunctionDec 19, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED INSERTING THE NASOGASTRIC (NG) INTO THE PATIENT THE REGISTERED NURSES (RN'S) NOTICED STOMACH CONTENT LEAKING ONTO THE BED FROM THE EXTERIOR END OF THE NG TUBE. "UPON FURTHER INSPECTION, A CRACK IN THE NG WAS NOTED AND THAT IS WHERE THE CONTENT WAS COMING OUT OF. ANOTHER NG TUBE WAS INSERTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857645 ↗
• MalfunctionJul 18, 2025Crack; Crack

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00160 FOR THE SECOND EVENT. IT WAS REPORTED THE PATIENT "PRESENTED TO HOSPITAL WITH 3-DAY HISTORY OF EMESIS, COUGH, INCREASED SECRETIONS, AND NEW SUPPLEMENTAL O2 [OXYGEN] NEED QUERY VIRAL ILLNESS. ADMITTED FOR SUPPORTIVE MANAGEMENT. CONTINUED TO HAVE EMESIS (FORMULA) AND NJ [NASO JEJUNAL] PLACEMENT CONFIRMED, HOWEVER, REMOVED AND FOUND TO BE CRACKED." ADDITIONAL INFORMATION RECEIVED 20-JUN-2025 NOTED NO FURTHER PATIENT IMPACT REPORTED. THE NJ TUBE WAS REPLACED. THE NJ TUBE WAS BEING USED FOR CONTINUOUS NJ FEEDS. THE ONLY MEDICATION GIVEN VIA THE NJ WAS PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] WAS POWDER DISSOLVED IN FORMULA/WATER. THE TUBE WAS FLUSHED EVERY FOUR HOURS WITH A 12 ML SYRINGE. ADDITIONAL INFORMATION RECEIVED 24-JUN-2025 NOTED THE PATIENT WAS FOUND TO HAVE ASPIRATION PNEUMONITIS/PNEUMONIA AND REQUIRED SUPPLEMENTAL OXYGEN AS A RESULT.

  Patient problems: Cough; Low Oxygen Saturation; Salivary Hypersecretion; Vomiting

  MAUDE report 22544135 ↗
• MalfunctionJul 18, 2025Crack; Crack

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00159 FOR THE FIRST EVENT. IT WAS REPORTED THE NASO JEJUNAL TUBE WAS REMOVED AND FOUND TO HAVE CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 22543985 ↗
• MalfunctionJul 10, 2025Fracture; Fracture

  IT WAS REPORTED THE TUBE WAS BALLOONING INSIDE THE PATIENT. IT APPEARED FRACTURED ON X-RAY BUT REMOVED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469223 ↗
• MalfunctionMar 12, 2025Leak/Splash; Stretched; Leak/Splash; Stretched

  PER ADDITIONAL INFORMATION RECEIVED ON 12MAR2025, DISTRIBUTOR CONFIRMS THE LEAK OCCURRED ON A PORTION OF THE TUBE THAT WAS INSIDE OF THE PATIENT.

  Patient problems: Vomiting

  MAUDE report 21587963 ↗
• MalfunctionJan 15, 2025Fracture; Fracture

  IT WAS REPORTED; TUBE WAS INSERTED ON (B)(6) 2024. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER A COUPLE OF WEEKS. THE TUBE WAS FOUND TO BE COMPLETELY FRACTURED. THE PROXIMAL PART OF THE TUBE WAS REMOVED FROM THE PATIENT. THE DISTAL PART OF THE TUBE REMAINS IN THE PATIENT, WHO HAS SINCE BEEN TRANSFERRED TO ANOTHER HOSPITAL. PER ADDITIONAL INFORMATION RECEIVED ON 19DEC2024, AN X-RAY WAS ORDERED WHEN THE PATIENT BECAME UNWELL. PART OF TUBE REMAINS IN THE PATIENT STOMACH AND MAY REQUIRE A FURTHER OPERATION TO REMOVE IT. PER MHRA REPORT RECEIVED ON 20DEC2024, "CT ABDO SHOWS TUBE STILL IN STOMACH- RISK OF OBSTRUCTION- HOWEVER DECISION TO WAIT AND SEE IF ANY SYMPTOMS."

  Patient problems: Foreign Body In Patient

  MAUDE report 21158882 ↗
• MalfunctionSep 13, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) THE FOLLOWING INFORMATION: INITIAL NG PLACED WHILE UNDER SEDATION FOR MRI PROCEDURE. [5 DAYS LATER]: INCIDENTAL FINDING OF A BREAK IN THE NG ON X-RAY. LINES/DEVICES: THERE IS TRANSPYLORIC TUBE WITH THE TIP AT THE LEVEL OF THE DISTAL STOMACH. PORTION OF THE TUBE MORE PROXIMALLY IN THE STOMACH IS DISCONTINUOUS. LEFT ARM PICC WITH THE TIP AT THE LEVEL OF THE MID SVC. ADDITIONAL VASCULAR CATHETER TIP OVERLYING THE SUPERIOR CAVOATRIAL JUNCTION. IMPRESSION: BREAK IN THE PORTION OF THE TRANSPYLORIC TUBE AT THE LEVEL OF THE PROXIMAL STOMACH. REMAINDER OF SUPPORT APPARATUS AS ABOVE. [6 DAYS AFTER INITIAL PLACEMENT]: UPPER GI ENDOSCOPY PERFORMED FOR FOREIGN BODY REMOVAL FROM STOMACH UNDER GENERAL ANESTHESIA BY MD. NG TUBE WITH LATERAL RUPTURE FOUND IN STOMACH AND REMOVED INTACT THROUGH NARES. NGT REPLACED. UPON RECEIVING PATIENT ON FLOOR FROM OR, NEWLY PLACED NG WAS FLUSHED AND TINY HOLE FOUND AT THE JUNCTION BETWEEN THE HUB AND NG CAUSING A LEAK. MD NOTIFIED AND DECIDED BY TEAM TO LEAVE NG IN FOR NOW TO ALLOW PATIENT TO REST FOR TODAY AND ASSESS REPLACEMENT TOMORROW. [7 DAYS AFTER INITIAL PLACEMENT]: IN MORNING RN

  Patient problems: Foreign Body In Patient

  MAUDE report 20212696 ↗