AVANOS 40-7368Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00350770460314), received between Feb 18, 2021 and Sep 28, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Leak/Splash; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915837 ↗
• MalfunctionSep 22, 2026Fracture

  It was reported that nasogastric tube was inserted in a patient who vomits regularly. Once the tube was in place and they began suctioning the gastric fluid, suctioning was very easy. When they decided to inject some water, a crack was noticed in the tube near the valve.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859472 ↗
• MalfunctionJul 20, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876216 ↗
• MalfunctionJul 20, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876212 ↗
• MalfunctionJul 17, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25862168 ↗
• MalfunctionJul 17, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: Feeding Problem

  MAUDE report 25861599 ↗
• MalfunctionJul 17, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855935 ↗
• MalfunctionJul 17, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855932 ↗
• MalfunctionJun 16, 2026Leak/Splash

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE LEAKED FROM THE SOLID CLEAR PLASTIC PORTION AS IF THE DEFECT WAS IN THE TUBE. THEY HAD TO TAKE THE TUBE OUT OF THE PATIENT AND PUT A NEW TUBE IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519004 ↗
• MalfunctionApr 22, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A TUBE WAS FOUND TO HAVE A HOLE IN IT AFTER INSERTION. THE PATIENT IS DOING WELL, AND THERE HAVE BEEN NO CONSEQUENCES. THE LUBRICATION OF THE TUBE HAD NOT BEEN ACTIVATED BY INJECTING WATER PRIOR TO REMOVAL OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954920 ↗
• MalfunctionMar 2, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00080 FOR THE FIRST REPORT. IT WAS REPORTED, "THE SAME ISSUE OCCURRED WITH THE SECOND TUBE. SECOND TUBE WAS REMOVED. THIRD TUBE WAS INSERTED WITHOUT FAULT. NO PATIENT INJURY OCCURRED, NO MEDICAL INTERVENTION." THE TUBE WAS FOUND TO BE SPLIT AT THE ADMINISTRATION PORT END.

  Patient problems: Insufficient Information

  MAUDE report 24490183 ↗
• MalfunctionMar 2, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00081 FOR THE SECOND REPORT. IT WAS REPORTED, "UNFORTUNATELY, ON THE FIRST ATTEMPT, THE TUBE WAS FOUND TO BE SPLIT AT THE ADMINISTRATION PORT END. THE TUBE WAS REMOVED, AND ANOTHER ONE WAS INSERTED." HOWEVER, THE SAME ISSUE OCCURRED WITH THE SECOND TUBE. SECOND TUBE WAS REMOVED. THIRD TUBE WAS INSERTED WITHOUT FAULT. NO PATIENT INJURY OCCURRED, NO MEDICAL INTERVENTION, NO INTERNAL OR EXTERNAL REPORTS."; DEFECT OCCURRED OUTSIDE OF THE PATIENT; GX. (B)(6) 2026 THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE BASED ON OUR REPORTING STRATEGY ACTIVE AT THE TIME OF THE ALERT DATE; HOWEVER, FOLLOWING A RECENT RETROSPECTIVE REVIEW OF COMPLAINTS THIS EVENT WAS MADE REPORTABLE OUT OF AN ABUNDANCE OF CAUTION. (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 24490181 ↗
• MalfunctionFeb 17, 2026Material Puncture/Hole

  IT WAS REPORTED, DURING THE DAY SHIFT, AN NG [NASOGASTRIC] TUBE WAS INSERTED AND ITS PLACEMENT WAS CONFIRMED BY X-RAY. THE WRITER SUBSEQUENTLY VERIFIED THAT THE NG TUBE PLACEMENT WAS ACCEPTABLE TO BEGIN ENTERAL FEEDS AND MEDICATION ADMINISTRATION. AT 2130, AN ATTEMPT WAS MADE TO ADMINISTER MEDICATIONS; HOWEVER, THE WRITER WAS UNABLE TO ASPIRATE FOR PH CONFIRMATION. THE WRITER THEN ATTEMPTED TO INSTILL 3 ML OF STERILE WATER TO ASSESS LINE PATENCY AND OBTAIN A PH SAMPLE. STERILE WATER WAS OBSERVED LEAKING FROM THE NG TUBE, AND THE WRITER NOTED TWO HOLES LOCATED JUST BELOW THE ENFIT ADAPTER PORTS. THE NG TUBE WAS SUBSEQUENTLY REMOVED. PER ADDITIONAL INFORMATION RECEIVED ON 29JAN2026, THE DISTRIBUTOR CONFIRMED THAT THE QUANTITY OF DEFECTIVE PRODUCT INVOLVED WAS ONE. THEY REPORTED THAT THE PATIENT WAS REQUIRED TO REMAIN PARENTERALLY FED WITH IV FLUIDS OVERNIGHT UNTIL A NEW NG TUBE COULD BE INSERTED. THE DISTRIBUTOR ALSO STATED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE LEAKAGE; HOWEVER, THE PATIENT WAS UNABLE TO RECEIVE ENTERAL NUTRITION UNTIL THE NG TUBE WAS REPLACED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367282 ↗
• MalfunctionNov 26, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A FEEDING TUBE INSERTED ON (B)(6) 2025 AND HAS BEEN BLOCKED SINCE (B)(6) 2025, WHICH WAS THE FIRST ATTEMPT TO BE CLEARED WITH HOT WATER. ATTEMPTED "TO CLEAR THE BLOCKAGE WITH COCA-COLA. THEY MANAGED TO INJECT A SMALL AMOUNT, THEN LET IT SIT. UPON THE PATIENT'S RETURN, THE PATIENT EXPERIENCED SHARP PAIN DURING ANOTHER ATTEMPT TO UNBLOCK. UPON REMOVAL OF THE TUBE, IT WAS OBSERVED THE FEEDING TUBE BALLOONED." THERE WAS NO REPORTED INJURY.

  Patient problems: Pain

  MAUDE report 23661566 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED "ATTEMPTED TO GET PH FROM [NASOGASTRIC] NG TUBE AT 1400-HOURS PRIOR TO MEDICATION ADMINISTRATION. UNABLE TO GET ASPIRATE. REPOSITIONED PATIENT HAD SECOND [REGISTERED NURSE] RN ATTEMPT TO GET PH AND RETAPED NG TUBE, STILL UNABLE TO GET PH. [MEDICAL DOCTOR] MD NOTIFIED...CHEST X-RAY DONE. KINK IN NG TUBING SEEN ON X-RAY. NG TUBE REMOVED, TEAR IN TUBING NOTED. NEW NG TUBE INSERTED, GOT ASPIRATE PH OF 2, NG TUBE NOW IN USE AGAIN." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384077 ↗
• MalfunctionMar 4, 2024Difficult to Remove; Use of Device Problem; Obstruction of Flow; Malposition of Device; Material Twisted/Bent; Difficult to Remove; Use of Device Problem; Obstruction of Flow; Malposition of Device; Material Twisted/Bent

  IT WAS REPORTED, "NASOGASTRIC TUBE INSERTION IN A 3-YEAR-OLD CHILD. THE PROCEDURE WENT WELL, AND A WEIGHTED, GUIDED CH8 TUBE WAS QUICKLY INSERTED. WHEN TRYING TO REMOVE THE GUIDE WITH A CATHETER IN PLACE, IT WAS IMPOSSIBLE TO PULL IT OUT, SO WE TRIED SEVERAL TIMES BEFORE FINALLY GIVING IN AND PULLING IT OUT WITH FORCE. WHEN IT CAME TIME TO INJECT AIR TO LISTEN TO THE CORRECT POSITIONING OF THE PROBE IN THE STOMACH, IT WAS IMPOSSIBLE TO INJECT ANYTHING. EVEN GETTING THE CHILD TO DRINK DIDN'T HELP. X-RAY CHECK ORDERED, SHOWING AN ANGLED PROBE THAT WENT DOWN INTO THE OESOPHAGUS BUT CAME UP IN THE MIDDLE OF THE OESOPHAGUS. THE TUBE WAS SUBSEQUENTLY REMOVED AND A NEW ONE INSERTED. PER ADDITIONAL INFORMATION RECEIVED ON 12FEB2024, ¿THE NASOGASTRIC TUBE WAS NOT FLUSHED WITH 10 ML OF WATER BEFORE REMOVAL OF THE STYLET/GUIDEWIRE. WE'VE ALREADY MADE THE CUSTOMER AWARE OF THE IMPORTANCE OF FLUSHED THE TUBE WITH 10 ML OF WATER BEFORE REMOVAL OF THE STYLET/GUIDEWIRE.¿

  Patient problems: Insufficient Information

  MAUDE report 18825062 ↗
• MalfunctionOct 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE NASOGASTRIC TUBE (NGT) WAS REMOVED, THE WEIGHTED PART WAS MISSING, AND THE GUIDE WAS STILL IN PLACE ON THE PROBE. NO INJURY REPORTED. THE PATIENT'S STATUS WAS REPORTED TO BE OK. PER ADDITIONAL INFORMATION RECEIVED ON 5-OCT-2022, THE REPORTER BELIEVES THE INCIDENT OCCURRED WHILE THE NGT WAS INSIDE OF THE PATIENT. HOWEVER, AN X-RAY WAS PERFORMED AND DID NOT FIND ANY FOREIGN BODY INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15618942 ↗
• MalfunctionJul 20, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CRACK OCCURRED ON PORTION OF THE TUBE THAT WAS INSIDE OF THE PATIENT. NO INJURY REPORTED. IT WAS ALSO REPORTED THAT THE STYLET WAS LEFT INSIDE THE PATIENT AND WAS DIFFICULT TO REMOVE. ADDITIONAL INFORMATION RECEIVED 22-JULL-2022 STATED "PROBE PLACED BY THE ANESTHESIOLOGIST IN THE OPERATING ROOM. WHEN THE CHILD RETURNS TO THE WARD, HE COMPLAINS OF PAIN IN HIS THROAT. I NOTICE THAT THE PROBE GUIDE IS STILL PRESENT AND THAT THE PROBE IS TWISTED AND HELD BY STRIPS. I FIRST TRY TO REMOVE THE GUIDE BUT I HAVE A RESISTANCE. I FINALLY MANAGED TO REMOVE THE GUIDE BUT WHEN I CHECKED THE LOCATION, I COULD NOT HEAR ANY AIR IN THE STOMACH AND I HAD NO GASTRIC RETURN. THE DOCTORS WERE INFORMED AND DECIDED TO TAKE AN X-RAY TO VERIFY THE LOCATION. ON THE X-RAY WE SEE THAT THE TUBE IS SLIGHTLY TWISTED IN THE STOMACH AND THAT IT NEEDS TO BE MOVED BACK SLIGHTLY. WHEN I GO BACK INTO THE ROOM TO PULL THE TUBE BACK SLIGHTLY, I TEST AGAIN AND END UP REALIZING THAT THE TUBE IS CRACKED SO WE NEED TO REMOVE IT. AFTER NEGOTIATING WITH THE CHILD, HE FINALLY AGREES TO LET US PUT IN A NEW ONE. I TEST THE GUIDE OF THE NEW CATHETER BEFORE PLACING IT AND NO PROBLEM WAS ENCOUNTERED. ONCE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071083 ↗
• MalfunctionJul 18, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2022-00101 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE PROBE WAS PLACED BY THE ANESTHESIOLOGIST IN THE OPERATING ROOM, WHEN THE CHILD WAS RETURNED TO THE WARD THEY COMPLAINED OF PAIN IN THEIR THROAT. IT WAS NOTED THAT THE PROBE GUIDE WAS STILL PRESENT AND THAT THE PROBE WAS TWISTED AND BEING HELD [IN] BY STRIPS. AN ATTEMPT WAS MADE, BY THE MEDICAL PROFESSIONAL TO REMOVE THE GUIDE BUT WAS MET WITH RESISTANCE, EVENTUALLY THE MEDICAL PROFESSIONAL MANAGED TO REMOVE THE GUIDE BUT WHEN THEY CHECKED THE LOCATION, THEY COULD NOT HEAR ANY AIR IN THE STOMACH AND THERE WAS NO GASTRIC RETURN. THE DOCTORS WERE INFORMED, AND AN X-RAY WAS USED TO VERIFY THE LOCATION. THE X-RAY REVEALED THAT THE TUBE WAS SLIGHTLY TWISTED IN THE STOMACH AND NEEDED TO BE MOVED BACK SLIGHTLY. WHEN AN ATTEMPT WAS MADE TO PULL THE TUBE BACK SLIGHTLY A TEST REVEALED THE TUBE WAS CRACKED. THE TUBE WAS REMOVED AND REPLACED WITH ANOTHER ONE.

  Patient problems: Pain

  MAUDE report 15048532 ↗
• MalfunctionJul 18, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2022-00100 FOR THE FIRST REPORT. THE GUIDE OF THE NEW CATHETER WAS TESTED BEFORE PLACING IT AND NO PROBLEM WAS ENCOUNTERED; HOWEVER, ONCE THE CATHETER WAS IN PLACE AND THE GUIDE WAS REMOVED A CRACK WAS NOTED, THAT WAS REPORTEDLY INSIDE THE PATIENT. THE NEWLY PLACED TUBE WAS REMOVED; THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048291 ↗
• MalfunctionOct 13, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00142 FOR THE FIRST REPORT. IT WAS REPORTED THAT A NG (NASOGASTRIC) TUBE WAS PLACED AND THE STYLET WAS DIFFICULT TO REMOVE AND CAUSED TEARING OF THE TUBE WHEN REMOVED. ANOTHER TUBE WAS PLACED IN THE PATIENT SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623628 ↗
• MalfunctionOct 13, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS ONE OF TWO REPORTS. REFER TO 9611594-2021-00143 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NG (NASOGASTRIC) TUBE WAS PLACED AND THE STYLET WAS DIFFICULT TO REMOVE AND CAUSED TEARING OF THE TUBE WHEN REMOVED. ANOTHER TUBE WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623625 ↗
• MalfunctionFeb 18, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NGT [NASOGASTRIC TUBE] WAS INSERTED ON (B)(6) 2020. IT WAS FOUND TO HAVE A LEAK/SPLIT AT THE 52CM MARK WHEN IT WAS REMOVED, AND THE PATIENT WAS FOUND TO HAVE "MILKY" COLORED SPUTUM. THE PATIENT REQUIRED REINTUBATION RELATED TO RESPIRATORY FAILURE. ADDITIONAL INFORMATION RECEIVED 08-FEB-2021 INDICATED THE PATIENT WAS "DISCHARGED SATISFACTORILY."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Respiratory Failure

  MAUDE report 11345934 ↗