AVANOS 42-9366Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00350770460918), received between Nov 1, 2023 and Sep 18, 2026 — classified as 11 malfunctions.

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

• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820106 ↗
• MalfunctionSep 18, 2026Fracture; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820098 ↗
• MalfunctionSep 18, 2026Fracture; Material Twisted/Bent

  Avanos Medical Inc. received a single report that referenced four different incidents, which were associated with separate units, involving two different patients. This is the second of four reports.Refer to 9611594-2026-00713 for the first reportRefer to 9611594-2026-00714 for the second report Refer to 9611594-2026-00715 for the third report Refer to 9611594-2026-00716 for the fourth report It was reported that a nasogastric feeding tube was removed because it had kinked. Upon removed, a split was noted in the tube. An X-ray was performed and the tube removed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820089 ↗
• MalfunctionSep 18, 2026Complete Blockage; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820088 ↗
• MalfunctionMay 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TUBE WAS FOUND TO BE LEAKING AIR (ENTRAINING AIR) FROM THE TOP OF THE TUBE NEAR TO WHERE THE GUIDEWIRE IS LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154859 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE INSERTED FEEDING TUBE HAS A HOLE IN THE DISTRIBUTION PIECE. THE CHILD WAS UNDER SEDATION FOR THE INITIAL PLACEMENT, AND THE FEEDING TUBE HAD TO BE INSERTED A SECOND TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093452 ↗
• MalfunctionMay 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "THERE WAS A HOLE IN THE NG [NASOGASTRIC] TUBE AS WHEN [THE CLINICIANS] ASPIRATED ONLY AIR WAS COMING UP EVEN THOUGH IT WAS CONFIRMED THAT THE TUBE WAS IN THE STOMACH. WHEN [THE CLINICIANS] SWAPPED TO A NEW NGT IT WORKED CORRECTLY." THERE WAS NO REPORTED INJURY BUT THERE WAS "SOME DISCOMFORT/LOW PSYCHOLOGICAL HARM FROM HAVING TO REPLACE NJT [NASOJEJUNAL TUBE]."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032013 ↗
• MalfunctionSep 24, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, ¿SIZE 6 FR 91CM TUBES WAS PASSED ON A PATIENT AND WAS UNABLE TO ASPIRATE. WHEN REMOVED, IT WAS FOUND THAT THE GUIDEWIRE HAD LEFT A HOLE IN THE TUBE.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20290076 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THERE WAS A "BROKEN TUBE IN THE STOMACH OF THE [PATIENT]. A [PATIENT] WHO UNDERWENT A LIVER TRANSPLANT, WHEN THEY DID AN X-RAY FOR OTHER REASONS, THEY DETECTED IN THE IMAGE THAT THE TIP IS CONNECTED BY A THREAD TO THE REST OF THE TUBE. THE TUBE HAS BEEN IN PLACE FOR 22-DAYS AND NO ONE HAS NOTICED ANYTHING, IT HAS BEEN PERMEABLE AT ALL TIMES, AND THEY HAVE NOT NOTICED ANY RESISTANCE IN THE ADMINISTRATION OF NUTRITION OR MEDICATION." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202963 ↗
• MalfunctionJun 19, 2024Material Rupture; Stretched; Material Rupture; Stretched

  IT WAS REPORTED, BROKEN TUBE. TUBE WAS IN USE FOR 15-30 DAYS. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PICTURE PROVIDED SHOWED TUBE BALLOONED, STRETCHED AND APPEARED TO RUPTURE BELOW THE 15CM MARK. PER ADDITIONAL INFORMATION RECEIVED ON 31MAY2024, THE RETAINED PORTION OF THE TUBE WAS REMOVED VIA ENDOSCOPY. PATIENT EXPERIENCED VOMITING. NUTRITION WAS STOPPED, AND THE RETAINED PORTION OF THE TUBE WAS REMOVED VIA ENDOSCOPY WITH ANESTHESIA.

  Patient problems: Feeding Problem; Vomiting

  MAUDE report 19567289 ↗
• MalfunctionNov 1, 2023Material Rupture; Stretched; Obstruction of Flow; Material Rupture; Stretched; Obstruction of Flow

  IT WAS REPORTED, THE NASOJEJUNAL TUBE (NJT) HAD BEEN PLACED SINCE (B)(6) 2023 AND HAD AN OCCLUSION ALARM AT APPROXIMATELY 0715 ON (B)(6) 2023. AT 0745, UNABLE TO FLUSH NJT. ABDOMINAL X-RAY CONFIRMED POSITION IN DISTAL DUODENUM AND THAT THE NJT WAS BLOCKED AND REQUIRED REPLACEMENT. STAFF ATTEMPTED TO REMOVE BUT MET A LOT OF RESISTANCE. STEADY TRACTION APPLIED FOR INTERVALS OF 20-30 SECONDS. THE NJT WAS MOVED APPROXIMATELY 6CM AND STOPPED AGAIN. FURTHER STEADY TRACTION APPLIED AND THE PROXIMAL END OF NJT CAME AWAY. THE PROXIMAL END HAD A DILATED APPEARANCE, LIKE A BURST BALLOON. ESTIMATED 20CM OF THE NGT STILL LEFT INTERNALLY. THE PATIENT WAS STABLE. ¿RE- X-RAY SHOWED TIP OF NJT AT LEVEL OF PYLORUS AND LENGTH OF TUBE THE ENTIRE LENGTH OF OESOPHAGUS QUERY UP TO ORAL CAVITY. EXAMINATION WITH TONGUE DEPRESSOR DID NOT SHOW AN OBVIOUS TIP.¿ THE IMPRESSION OF THE NJ TUBE WAS ¿DEGRADATION/DEFECT CAUSING DILATION/BLOCKAGE AT BREAKAGE POINT OF NJT.¿ MEDICAL TREATMENT INCLUDED, ¿COMMENCED ON IV FLUIDS. X-RAY SHOWED TIP OF NJT AT LEVEL OF PYLORUS AND LENGTH OF TUBE THE ENTIRE LENGTH OF OESOPHAGUS QUERY UP TO ORAL CAVITY. DECISION TO TRIAL VISUALISATION WITH DIRECT LARYNGOSCOPY/VIDEO LARYNGOSCOP

  Patient problems: Foreign Body In Patient

  MAUDE report 18051836 ↗