AVANOS 42-7368Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770460826), received between Mar 19, 2025 and Jun 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Leak/Splash

  IT WAS REPORTED, A LEAKAGE OCCURRED WHICH REQUIRED REPLACEMENT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25488459 ↗
• MalfunctionJun 11, 2026Material Split, Cut or Torn

  IT WAS REPORTED, LEAK WAS NOTICED AFTER STARTING ENTERAL FEEDING, ALTHOUGH NO ISSUES WERE OBSERVED WHEN FLUSHING THE TUBE AFTER OPENING THE PACKAGE. A VISIBLE TEAR WAS FOUND NEAR THE Y-CONNECTOR AREA OF THE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 25472272 ↗
• MalfunctionJun 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, "THERE WAS A TEAR UNDER Y-CONNECTOR." THE DEVICE WAS REPLACED WITH ANOTHER TUBE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399722 ↗
• MalfunctionApr 22, 2026Complete Blockage; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A CORFLO NASOGASTRIC TUBE BECAME BLOCKED ON (B)(6) 2025. WHEN TRYING TO UNBLOCK THE TUBE, THE TUBE WAS BALLOONING IN A SECTION OUTSIDE THE NOSTRIL OF THE PATIENT. TUBE WAS REMOVED AND RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954960 ↗
• MalfunctionApr 20, 2026Leak/Splash; Material Puncture/Hole; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT HAD A FINE BORE NASOGASTRIC TUBE INSERTED. THE INSERTION HAPPENED WITHOUT ISSUES, BUT THE GUIDEWIRE WAS DIFFICULT TO REMOVE. NO ASPIRATE COULD BE OBTAINED, SO THE PATIENT WAS SENT FOR AN X-RAY. TUBE WAS PLACED CORRECTLY. WHEN MEDICATION WAS GIVEN THROUGH THE TUBE, IT SQUIRTED OUT OF A HOLE AT THE BOTTOM OF THE TUBE, NEAR THE CAP. THE TUBE WAS REMOVED, AND A NEW ONE PLACED 2 HOURS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932376 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED "SEEMED THAT NG [NASOGASTRIC] TUBE WAS CLOGGED AND THE TUBE WAS TORN WHEN A USER INJECTED LIQUID. THERE [ARE] NO RETAINED PARTS OF THE TUBE IN THE PATIENT'S BODY. THE NG TUBE WAS REPLACED FOR NEW ONE. NO PATIENT INJURY." ADDITIONAL INFORMATION RECEIVED 23-APR-2025 STATING, "IT WAS REPORTED THAT IT OCCURRED INSIDE OF THE PATIENT. FOR NOW, NO PATIENT INJURY NOR MEDICAL INTERVENTION WERE REPORTED." ADDITIONAL INFORMATION RECEIVED 16-MAY-2025 STATING, THE TUBE WAS INSERTED ON (B)(6). ON (B)(6), A (COMPUTED TOMOGRAPHY) CT SCAN WAS PERFORMED TO INVESTIGATE THE CAUSE OF A FEVER, AND A FOREIGN OBJECT WAS FOUND IN THE DUODENUM. IT WAS ENDOSCOPICALLY REMOVED ON (B)(6).

  Patient problems: Fever; Foreign Body In Patient

  MAUDE report 22065711 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED, ¿TUBE BREAK INSIDE THE PATIENT. THE PATIENT WAS IN ICU [INTENSIVE CARE UNIT]. THE NURSE WENT TO FLUSH AND NOTICED FEED STARTING LEAKING AND THEY X RAYED AND NOTICED THE TUBE HAD BROKEN. THE PATIENT IS IN A STABLE BUT SERIOUS CONDITION CURRENTLY. THE TUBE WAS NOT BLOCKED.¿ PER ADDITIONAL INFORMATION RECEIVED ON 26FEB2025, ¿THE TUBE BROKE WHILE BEING FLUSHED TO CLEAR A BLOCKAGE. NURSING STAFF NOTICED WATER COMING FROM THE PATIENT'S MOUTH HAVING FLUSHED THE TUBE. PATIENT IS IN ICU FULLY SEDATED. TUBE WAS THEN REMOVED AND NOTICED TO BE ONLY HALF A TUBE. BOTTOM PART OF THE TUBE WAS THEN REMOVED WITH INTUBATION EQUIPMENT. BOTH PARTS OF THE TUBE HAVE BEEN KEPT AND CAN BE RETURNED.¿ IT WAS ADDITIONALLY REPORTED, MEDICAL INTERVENTIONS INVOLVED ¿REMOVAL OF NG WITH INTUBATION EQUIPMENT. THE PATIENT MISSED FEEDS AND HAD TO HAVE A SECOND TUBE PASSED. THE PATIENT¿S CURRENT CONDITION IS STABLE. THE TUBE WAS 10 DAYS IN SITU. THE PATIENT WAS ON CONTINUOUS FEEDING. THE TUBE WAS USED FOR MEDICATION ADMINISTRATION. THE TUBE WAS FLUSHED BEFORE AND AFTER ANY MEDICATIONS AND BEFORE AND AFTER CONNECTING AND DISCONNECTING THE FEED. WE WOULD ESTIMATE THE TUBE WAS FLUSHED ABOUT 6 TIMES DAILY

  Patient problems: Feeding Problem; Foreign Body In Patient

  MAUDE report 21691693 ↗
• MalfunctionMar 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED "PATIENT HAD A CORTRAK NG (NASOGASTRIC) [TUBE] IN SITU FROM (B)(6)2025. THERE WERE ISSUES WITH THE NG WITH RESPECT TO BLOCKAGES AND DIFFICULTIES OBTAINING ASPIRATES FROM THE NG FROM (B)(6)2025. THE NG WAS BLOCKED ON THE MORNING OF THE (B)(6)2025, BUT NURSING STAFF MANAGED TO GET IT UNBLOCKED IN THE EVENING OF (B)(6)2025. THE NG WAS CONFIRMED BY CXR ON (B)(6)2025. ON THE (B)(6)2025 THE FEED WAS COMMENCED BUT STAFF NURSES NOTICED SOON AFTER THAT FEED WAS COMING FROM THE PATIENT¿S MOUTH AND NOSE. FEED WAS HELD. NG WAS REMOVED ON (B)(6)2025 AND DOCTOR NOTICED [TWO]BALLOONS IN THE TUBE (ONE AT END OF TUBE (DISTAL END) AND ONE AT APPROXIMATELY 20CM." "ON (B)(6)2025 A CXR [CHEST X-RAY] FROM (B)(6)2025 WAS REVIEWED BY THE TEAM INTERN AND ARTEFACT WAS NOTED IN THE OESOPHAGEAL/STOMACH SPACE. THIS WAS CONFIRMED AS REMANENT ON AN NG TUBE. DIETITIAN NOTIFIED (B)(6)2025. PATIENT WENT TO ENDOSCOPY AND HAD THE ARTEFACT REMOVED ¿ 35CM PIECE OF NG TUBE WITH BALLOONING. TUBE RETAINED." ADDITIONALLY, IT WAS NOTED THE "PATIENT BECAME VERY UNWELL BUT DIFFICULT TO TELL IF FROM BROKEN TUBE AND FEED COMING OUT MOUTH AND NOSE." THE PATIENT'S CURRENT STATUS, "WAS VERY UNWELL BUT MORE STABLE N

  Patient problems: Foreign Body In Patient

  MAUDE report 21646557 ↗