AVANOS 42-7361Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00350770460802), received between Jun 23, 2022 and Jun 25, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00504 FOR THE FIRST REPORT. REFER TO 9611594-2026-00505 FOR THE SECOND REPORT. THE CUSTOMER REPORTED THAT THREE CORFLO FEEDING TUBES WERE FOUND WITH HOLES BELOW THE Y-CONNECTOR DURING USE. THE DEVICES WERE REPLACED WITH NEW FEEDING TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25624038 ↗
• MalfunctionJun 25, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00504 FOR THE FIRST REPORT. REFER TO 9611594-2026-00506 FOR THE THIRD REPORT. THE CUSTOMER REPORTED THAT THREE CORFLO FEEDING TUBES WERE FOUND WITH HOLES BELOW THE Y-CONNECTOR DURING USE. THE DEVICES WERE REPLACED WITH NEW FEEDING TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25624035 ↗
• MalfunctionJun 25, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00505 FOR THE SECOND REPORT. REFER TO 9611594-2026-00506 FOR THE THIRD REPORT. THE CUSTOMER REPORTED THAT THREE CORFLO FEEDING TUBES WERE FOUND WITH HOLES BELOW THE Y-CONNECTOR DURING USE. THE DEVICES WERE REPLACED WITH NEW FEEDING TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25624031 ↗
• MalfunctionJun 25, 2026Flushing Problem; Leak/Splash

  THE CUSTOMER REPORTED LEAKAGE OF ENTERAL NUTRITION FROM THE MIDDLE PORTION OF A CORFLO FEEDING TUBE DURING USE. PRIOR TO USE, RESISTANCE WAS ENCOUNTERED WHILE FLUSHING WATER THROUGH THE TUBE; HOWEVER, THE OBSTRUCTION APPEARED TO CLEAR, AND THE TUBE CONTINUED TO BE USED. SUBSEQUENTLY, LEAKAGE WAS OBSERVED FROM THE MIDDLE SECTION OF THE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619639 ↗
• MalfunctionMay 19, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A NASOGASTRIC TUBE LEAKED OUTSIDE THE PATIENT. THERE WAS A HOLE. NO MEDICAL INTERVENTION AND NO INJURIES TO THE PATIENT. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218728 ↗
• MalfunctionMay 11, 2026Fracture; Leak/Splash

  IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS PLACED ON (B)(6) 2025. TUBE FOUND TO BE LEAKING ON 21-AUG-2025. A SMALL TEAR WAS IDENTIFIED JUST ABOVE THE FEEDING PORT WHEN ADMINISTERING MEDICATION. FEED WAS STOPPED AS A RESULT AND THE TUBE WAS REMOVED (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137467 ↗
• MalfunctionMay 5, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A NASOGASTRIC TUBE BULGING. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081157 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THE NASOGASTRIC (NGT) WAS PLACED IN THEATRE ON (B)(6) 2024. THE TUBE STARTED LEAKING WITHIN HOURS AFTER FEEDING COMMENCED ON 26-JUL-2024. A PINHOLE IDENTIFIED ON THE TUBE JUST BELOW THE Y-ADAPTER. THE FEED WAS HELD AS A RESULT OF THE LEAKING TUBE AND NGT REMOVED ON (B)(6) 2024. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903757 ↗
• MalfunctionFeb 18, 2026Crack; Leak/Splash

  IT WAS REPORTED, ¿THE PATIENT'S GOWN WAS WET, SEVEN HOURS AFTER NASOGASTRIC (NG) TUBE PLACEMENT. CHECKED THE TUBE AND FOUND A CRACK ON IT. NO FEEDING HAS NOT BEEN DONE THROUGH NG TUBE. SINCE THERE WAS LEAKAGE OF GASTRIC JUICE FROM THE DAMAGED PART, IT WAS PROTECTED WITH A PLASTIC BAG. NO PATIENT INJURY.¿

  Patient problems: Feeding Problem

  MAUDE report 24379165 ↗
• MalfunctionJan 15, 2026Fracture

  IT WAS REPORTED THE DEVICE WAS INSERTED (B)(6) 2025 AND SUTURED IN PLACE BY THE...PLASTIC SURGERY TEAM." ON [(B)(6) 2025] RESISTANCE TO FLUSHING WORSENED DURING THE DAY AND ATTEMPTS WERE MADE TO UNBLOCK WITH VARIOUS SIZE SYRINGES. THE NURSE RECORDED "SOME CONTENTS RETURNING VIA NOSE AND MOUTH, SO DECISION MADE TO REMOVE NGT (NASOGASTRIC TUBE) SAME DONE AND OBVIOUS FRACTURE IN TUBING JUST PAST SUTURE MARK WHEN EXAMINED POST REMOVAL." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082997 ↗
• InjuryDec 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, THAT ¿THE STYLET WAS INADVERTENTLY LEFT IN-SITU AFTER TUBE WAS INSERTED.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23927505 ↗
• MalfunctionDec 10, 2025Break; Stretched; Obstruction of Flow; Break; Stretched; Obstruction of Flow

  IT WAS REPORTED, "NGT [NASOGASTRIC TUBE] PLACED IN ICU [INTENSIVE CARE UNIT] ON (B)(60 2025. TUBE BALLOONED AND BECAME BLOCKED (B)(6) 2025. THE TUBE BALLOONED AND THEN FRACTURED NEAR THE TOP. THE FEED WAS HELD AS A RESULT AND NGT REMOVED ON (B)(6) 2025." PER ADDITIONAL INFORMATION RECEIVED ON 26NOV2025, ¿IT FRACTURED OUTSIDE THE PATIENT AT THE TIP OF THE NOSE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769165 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THE "TUBE BREAKS, USED 1-MONTH." THERE WAS NO REPORTED INJURY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625000 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED "THE TUBE WAS PLACED PROPERLY WITH X-RAY AND THERE WERE SOME SHADOWS, SO GASTROSCOPY WAS PERFORMED, AND IT WAS DETECTED THAT SOME TUNGSTEN WEIGHTS WERE LEFT IN [THE PATIENT'S] STOMACH. THE TUBE WAS ALREADY DISCARDED, BUT 10 TUNGSTEN WEIGHTS WERE COLLECTED FROM THE STOMACH." THERE IS A POSSIBILITY THAT TWO "TUNGSTEN WEIGHTS ARE STILL LEFT IN THE STOMACH. FOR NOW, NO PATIENT INJURY NOR MEDICAL INTERVENTION WERE REPORTED."

  Patient problems: Foreign Body In Patient

  MAUDE report 21472101 ↗
• MalfunctionFeb 12, 2025Material Rupture; Obstruction of Flow; Material Rupture; Obstruction of Flow

  IT WAS REPORTED, ¿FEEDING ON FLOW, BLOCKED TUBE. ATTEMPTED TO FLUSH, UNABLE TO DO SO. PRESENTED TO HOSPITAL FOR PRE-PLANNED OESOPHAGOGASTRODUODENOSCOPY (OGD) ¿ NASOJENUNAL REMOVED BY UPPER GI SURGEONS ON IDENTIFICATION THAT THE TUBE HAD RUPTURED INSIDE THE INTESTINAL TRACT. TUBE HAD BLOCKED FEW WEEKS PRIOR AND WAS UNBLOCKED BY LOCAL HOSPITAL IN CLONMEL TIPPERARY USING CLOG ZAPPER (B)(6)2024). UNABLE TO IDENTIFY IF TUBE HAD RUPTURED AT THIS POINT. SIGNIFICANT CONCERN FROM SURGICAL CONSULTANT. RUPTURE APPEARED TO HAVE HAPPENED SOME TIME BEFORE TUBE BLOCKED FOR PATIENT, THEREFORE QUERY HAS TO HOW LONG PATIENT WOULD HAVE BEEN FEEDING THROUGH TUBE WITHOUT WARNING SIGN THAT THE TUBE HAD RUPTURED.¿ TUBE WAS IN PLACE FOR OVER THREE MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367954 ↗
• MalfunctionNov 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE "NASOGASTRIC TUBE WAS TO BE REPLACED AS IT WAS BELIEVED TO BE POSSIBLY COILED IN OROPHARYNX. IT WAS REMOVED BY [THE PHYSICIAN]. ON REMOVAL IT WAS EVIDENT THAT THE TUBE HAD RUPTURED AT THE LEVEL OF 65CM." THE "DISTAL END [WAS] RETRIEVED BY [THE INTENSIVE CARE UNIT] ICU MEDICAL TEAM AT THE BEDSIDE USING MAGILL'S FORCEPS/LARYNGOSCOPE. PATIENT SEDATED FOR THE PROCEDURE. ONGOING REVIEW BY ICU MEDICAL TEAM OVERNIGHT -NOTE STATES 'PATIENT HAS NEW ONSET VAP.' ANTIBIOTIC COVER INITIATED. ADDITIONAL INFORMATION RECEIVED 30-OCT-2024 STATES, "THIS IS VERY LIKELY ASSOCIATED WITH THIS INCIDENT BUT UNABLE TO CONFIRM DEFINITIVELY."

  Patient problems: Pneumonia

  MAUDE report 20750504 ↗
• MalfunctionAug 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, NUTRITION LEAKED FROM THE TUBE ON THE SAME DAY. THE TUBE WAS REMOVED FROM PATIENT. A TEAR WAS DETECTED AT 71CM MARK. IT WAS REPORTED THERE WERE NO SHARP-EDGED TOOLS USED IN CONJUNCTION WITH THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020882 ↗
• MalfunctionJul 25, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, AFTER REMOVING THE NASOGASTRIC TUBE, IT WAS FOUND THAT THERE WAS A PINHOLE IN THE MAIN BODY OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829585 ↗
• MalfunctionJul 17, 2024Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED, SPLIT (HOLE) IN A NASOGASTRIC (NG) TUBE. PER ADDITIONAL INFORMATION RECEIVED ON 26JUN2024, NG TUBE BLOCKED ON THE (B)(6) 2024 AND THE NG TUBE WAS UNBLOCKED WITH A 10ML SYRINGE USING A SODIUM BICARBONATE SOLUTION (1 TEASPOON OF SODIUM BICARBONATE MIXED WITH 30MLS OF STERILE WATER TO MAKE THE SOLUTION). SUBSEQUENTLY WHEN FLUSHED WITH STERILE WATER, THE PATIENT WAS COUGHING AND COULD FEEL THE WATER FLUSH IN HER UPPER OESOPHAGUS. THE NG TUBE WAS REMOVED AND ON REMOVAL A HOLE IN THE NG WAS FOUND AT 40CM. THE PRODUCT WAS IN USE SINCE 21MAY2024. CHEST X-RAY COMPLETED TO ASSESS CHEST STATUS WHEN THE HOLE IN THE NG WAS NOTED ¿ NIL MEDICAL INTERVENTION REQUIRED FOLLOWING CHEST X-RAY. GASTROSTOMY (PEG) PLACED (B)(6) 2024 REMAINS AN INPATIENT FOLLOWING A STROKE (B)(6) 2024.

  Patient problems: Cough

  MAUDE report 19766924 ↗
• MalfunctionJun 25, 2024Break; Leak/Splash; Obstruction of Flow; Break; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED, NASOGASTRIC (NG) TUBE WAS BLOCKED. ATTEMPTED TO UNBLOCK BUT TUBE BROKE IN HALF INSIDE THE PATIENT. A NEW NG TUBE WAS PLACED. PER ADDITIONAL INFORMATION RECEIVED ON 19JUN2024, NG WAS BLOCKED ON (B)(6) 2024 AND EFFORTS WERE MADE TO UNBLOCK WITH A 20ML SYRINGE USING SODIUM BICARBONATE SOLUTION (1 TEASPOON OF SODIUM BICARBONATE MIXED WITH 30MLS OF STERILE WATER). A SUBSEQUENT FLUSH WITH 10MLS OF STERILE WATER POOLED IN THE PATIENT¿S MOUTH. NG REMOVED. NG HAD BURST AT 48CM (EXTERNAL TUBE MARKINGS AT 57CM) WITH DISTAL END OF NG REMAINING INSIDE THE PATIENT. CHEST AND ABDOMINAL X-RAY FOLLOWED BY COMPUTED TOMOGRAPHY (CT) THORAX ABDOMEN AND PELVIS TO CONFIRM LOCATION OF THE DISTAL PART OF THE NG. NO OTHER MEDICAL INTERVENTION AS PATIENT WAS TOO UNWELL FOR REASONS UNRELATED TO THE NG. THE PATIENT DIED ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605858 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 9611594-2024-00118 FOR THE FIRST REPORT. REFER TO 9611594-2024-00119 FOR THE SECOND REPORT. REFER TO 9611594-2024-00120 FOR THE THIRD REPORT. REFER TO 9611594-2024-00122 FOR THE FIFTH REPORT. IT WAS REPORTED, NASOGASTRIC TUBE BURST IN INTENSIVE CARE UNIT (ICU). NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19567305 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 9611594-2024-00118 FOR THE FIRST REPORT. REFER TO 9611594-2024-00119 FOR THE SECOND REPORT. REFER TO 9611594-2024-00120 FOR THE THIRD REPORT. REFER TO 9611594-2024-00121 FOR THE FOURTH REPORT. IT WAS REPORTED, NASOGASTRIC TUBE BURST IN INTENSIVE CARE UNIT (ICU). NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19567302 ↗
• MalfunctionJun 19, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 9611594-2024-00119 FOR THE SECOND REPORT. REFER TO 9611594-2024-00120 FOR THE THIRD REPORT. REFER TO 9611594-2024-00121 FOR THE FOURTH REPORT. REFER TO 9611594-2024-00122 FOR THE FIFTH REPORT. IT WAS REPORTED, NASOGASTRIC TUBE BURST IN INTENSIVE CARE UNIT (ICU). NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER PICTURE OF THE ALLEGED PRODUCT RECEIVED ON 14APR2024, IMAGE SHOWED A PUNCTURE NEAR THE 59CM MARK.

  Patient problems: Insufficient Information

  MAUDE report 19567298 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 9611594-2024-00118 FOR THE FIRST REPORT. REFER TO 9611594-2024-00120 FOR THE THIRD REPORT. REFER TO 9611594-2024-00121 FOR THE FOURTH REPORT. REFER TO 9611594-2024-00122 FOR THE FIFTH REPORT. IT WAS REPORTED, NASOGASTRIC TUBE BURST IN INTENSIVE CARE UNIT (ICU). NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19567297 ↗
• MalfunctionJun 19, 2024Material Rupture; Material Rupture

  PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2024, NASOGASTRIC TUBE SPLIT WITHIN 24 HOURS. NO BLOCKAGES OCCURRED WITH THE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 19567294 ↗