AVANOS 40-8368Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00350770460376), received between Oct 19, 2021 and Jun 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Material Rupture; Stretched

  THE CUSTOMER REPORTED THAT WHILE FLUSHING A CORFLO PEDIATRIC FEEDING TUBE THAT HAD BEEN IN PLACE FOR APPROXIMATELY 6 WEEKS, THE PATIENT EXPERIENCED PAIN AND FELT THAT THE TUBE HAD "POPPED." THE TUBE WAS REMOVED AND A 1¿2 CM SECTION OF THE TUBING WAS FOUND TO BE BALLOONED. THE TUBE WAS REPLACED WITH A NEW DEVICE. THE REPORTING FACILITY INDICATED THE TUBE MAY HAVE BECOME BLOCKED BY CRUSHED MEDICATION AND THAT FORCEFUL FLUSHING MAY HAVE CAUSED THE BALLOONING. THE TUBE HAD BEEN DISCARDED; ONLY A PHOTOGRAPH WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664647 ↗
• MalfunctionJun 3, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A NURSE PLACED NG (NASOGASTRIC) TUBE, AND WHEN CHECKING PLACEMENT, WATER FROM FLUSH LEAKED FROM A HOLE DISCOVERED ON THE SIDE OF THE TUBE BY THE PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382184 ↗
• MalfunctionJun 2, 2026Fracture

  IT WAS REPORTED THAT A NURSE DISCOVERED NON-PATIENT DAMAGE TO NGT (NASOGASTRIC TUBE), CAUSING PATIENT TO NOT RECEIVE 2 HOURS¿ WORTH OF MEDICATION. DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364050 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  IT WAS REPORTED THE "NURSE PLACED TRANSPYLORIC (TP) TUBE IN PATIENT AND CONFIRMED IT VIA X-RAY. WHEN RN WENT TO FLUSH WATER, THE LIQUID CAME OUT OF SMALL HOLES AT THE TOP OF THE TP TUBE NEAR THE HUB. THE TP TUBE WAS PULLED AND ANOTHER TUBE HAD TO BE PLACED CAUSING A NOSEBLEED IN A PATIENT WITH LOW PLATELETS OF 37." THERE WAS NO REPORTED INJURY.

  Patient problems: Epistaxis

  MAUDE report 25094341 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  THE USER FACILITY REPORTED THAT AN 8 FRENCH CORFLO NASOGASTRIC FEEDING TUBE KINKED AT THE EXIT POINT OF THE NOSE WHEN SECURED TO THE PATIENT¿S CHEEK. THE TUBE WAS MANIPULATED AND REPOSITIONED MULTIPLE TIMES; HOWEVER, IT CONTINUED TO KINK, REQUIRING REMOVAL. PRIOR TO PLACEMENT, ANOTHER TUBE OF THE SAME TYPE WAS TESTED AND ALSO DEMONSTRATED A TENDENCY TO KINK WHEN SLIGHTLY BENT. THE PATIENT WAS SUBSEQUENTLY MANAGED WITH A 6 FRENCH CORFLO NASOGASTRIC TUBE WITHOUT ISSUE. IT WAS REPORTED THAT THE AFFECTED TUBES MAY BE MORE RIGID AND PRONE TO KINKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866037 ↗
• MalfunctionFeb 2, 2026Material Puncture/Hole

  IT WAS REPORTED, ¿NG (NASOGASTRIC) TUBE HAD A HOLE IN IT NEAR THE ENFIT ATTACHMENT PLACE; ADDITIONAL IMAGING OBTAINED, AND NEW TUBE PLACED. NG TUBE HAD A HOLE IN IT NEAR THE ENFIT ATTACHMENT PLACE. AS A RESULT, THE PATIENT RECEIVED A XRAY AND ALL MEDS AND FEEDS WERE LATE. NOT TO MENTION, WE HAD TO PLACE AN ADDITIONAL NG TUBE. (THAT WAS THE 8TH THAT SHIFT).', DEVICE WAS IN USE FOR PATIENT CARE, NO CONCURRENT DEVICE USAGE THAT WOULD CONTRIBUTE TO THE FAILURE."

  Patient problems: Feeding Problem

  MAUDE report 24236017 ↗
• MalfunctionJun 3, 2022Break; Break

  FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4). REPORTED: THE PATIENT WAS 2 DAYS POST-OP WHEN THE REGISTERED NURSE (RN) WAS TOLD BY THE DAY SHIFT RN THAT THE NASOGASTRIC TUBE (NG) HAD SOME RESISTANCE BUT WAS ABLE TO BE FLUSHED, IT WAS JUST SLOW. AT THE BEGINNING OF THEIR SHIFT THE RN WAS ABLE TO FLUSH THE NG TUBE WITH STERILE WATER WITHOUT ANY ISSUES. THE FOLLOWING MORNING THE RN ATTEMPTED TO FLUSH THE NG WITH STERILE WATER, TO CHECK IT BEFORE ADMINISTERING THE MEDICATION AND NOTED THAT STERILE WATER WAS COMING OUT OF THE PATIENT¿S NOSE. THE RN STOPPED THE FLUSH AND PULLED BACK ON THE TUBE AND REMOVED APPROXIMATELY 61 CM OF THE TUBE, THEY NOTED THAT THE END OF THE TUBE WAS BROKEN/SNAPPED. THE RN ALERTED THE PHYSICIAN (MD) AND A CHEST XRAY (CXRAY) AND KUB (CHEST XRAY AND KIDNEY, URETER, BLADDER X-RAY) WERE ORDERED. THE TEAM WAS AWARE THAT THE RN WAS UNABLE TO ADMINISTER THE MEDICATION TO THE PATIENT. BASED ON THE MEASUREMENT, APPROXIMATELY 29 CM OF THE WEIGHTED NG TUBING REMAINED INSIDE THE PATIENT, THIS WAS CONFIRMED BY THE C-XRAY. A PROCEDURE TO REMOVE THE REMAINING TUBING WAS PERFORMED: THE OROPHARYNX WAS FIRST CAREFULLY EXPOSED USING A TONGUE BLADE FOLLOWING THIS THE DISTAL EN

  Patient problems: Foreign Body In Patient

  MAUDE report 14599016 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 0533020000-2021-8013 THE FOLLOWING INFORMATION: PATIENT RECEIVING ENTERAL FEEDS AND MEDICATION THROUGH NG TUBE. PUMP ALARMED DOWNSTREAM OCCLUSION. TUBE WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE NG TUBE WAS NOT INTACT. ABDOMINAL X-RAY SHOWED THAT A FRAGMENT OF THE NG TUBE WAS RETAINED IN PATIENT'S STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 12857734 ↗
• MalfunctionOct 19, 2021Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00144 FOR THE FIRST REPORT. REFER TO 9611594-2021-00145 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE NURSE WENT TO CHECK GASTRIC CONTENTS TO CONFIRM PLACEMENT AND HEARD AN ODD WHISTLING SOUND AS THE SYRINGE WAS PULLED BACK. NASOGASTRIC (NG) TUBE WAS CHECKED AND FOUND TO HAVE A HOLE IN THE TUBING "NEAR THE TOP OF THE TUBE." A NEW TUBE WAS PLACED. PER ADDITIONAL INFORMATION RECEIVED 28 SEP 2021 IT WAS CLARIFIED THAT THE HOLE WAS ON THE DISTAL PORTION OF THE TUBE THAT WAS INSERTED INTO THE PATIENT'S STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656523 ↗
• MalfunctionOct 19, 2021Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2021-00145 FOR THE SECOND REPORT. REFER TO 9611594-2021-00146 FOR THE THIRD REPORT. IT WAS REPORTED THAT THERE WAS A PATIENT WHO HAD A NASOGASTRIC (NG) TUBE PLACED IN THE OPERATING ROOM (OR) AND IN POST-ANESTHESIA CARE UNIT (PACU) IT WAS DETERMINED TO BE LEAKING DUE TO A NOTABLE HOLE. PER ADDITIONAL INFORMATION RECEIVED 28 SEP 2021 IT WAS CONFIRMED THAT THE HOLE WAS ON THE DISTAL PORTION OF THE TUBE THAT WAS INSERTED INTO THE PATIENT'S STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656521 ↗
• MalfunctionOct 19, 2021Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00144 FOR THE FIRST REPORT. REFER TO 9611594-2021-00146 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE NURSE WENT TO CHECK GASTRIC CONTENTS TO CONFIRM PLACEMENT, BUT WAS UNABLE TO. RESISTANCE WAS MET WHEN TRYING TO ASPIRATE. UPON FURTHER INSPECTION A HOLE WAS FOUND NEAR THE ENFIT CONNECTION SITE. PER ADDITIONAL INFORMATION RECEIVED 28 SEP 2021 IT WAS CLARIFIED THAT THE HOLE WAS ON THE DISTAL PORTION OF THE TUBE THAT WAS INSERTED INTO THE PATIENT'S STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656509 ↗