AVANOS 40-9551Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770460529), received between Nov 22, 2022 and May 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Complete Blockage

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22977802, THE FOLLOWING: FEEDING TUBE THAT CLOGGED WITHIN 24 HOURS OF PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145483 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED "THE PRODUCT BROKE INTO TWO PARTS, WITH ONE PART RETAINED INSIDE THE PATIENT THAT REQUIRED ENDOSCOPIC REMOVAL." THE OVERNIGHT CLINICAL TEAM INSTRUCTED THE MORNING CLINICAL TEAM THAT THERE HAD BEEN A NURSING REPORT OF RESISTANCE TO THE NASOJEJUNAL (NJ) TUBE. THE TEAM CHECKED THE TUBE PLACEMENT WITH A CHEST/ABDOMINAL X-RAY THAT SHOWED NJ WITHIN THE PROXIMAL JEJUNUM. TEAM CLINICAL TEAM FOLLOWED POLICY AND PROCEDURE FOR UNBLOCKING ENTERAL TUBES AND USED WARM WATER/PANCREATIC ENZYMES. "FOLLOWING ADMINISTRATION THE MEDICAL TEAM WAS [WAS INSTRUCTED] THAT THERE WAS NO FURTHER RESISTANCE TO THE NJ TUBE AND SO NJ FEEDS WERE RESUMED." THE CLINICIAN REPORTED AT NOON TO REVIEW AN ABDOMINAL X-RAY AS THE NJ TUBE WAS REPORTED TO HAVE BROKEN WITH A LARGE PART LEFT INSIDE PATIENT. "THE FEEDS WERE PAUSED, AND THE [ABDOMINAL X-RAY] WAS COMPLETED THAT SHOWED A PORTION OF THE NJ TUBE BROKEN INSIDE." THE "FEEDS REMAINED PAUSED AND CALLED [THE GASTROENTEROLOGIST] TO DISCUSS MANAGEMENT. THE GASTROENTEROLOGIST "REVIEWED THE CASE AND ORGANIZED TAKING THE PATIENT TO THE [OPERATING ROOM] FOR ENDOSCOPY AND RETRIEVAL OF THE BROKEN NJ TUBE. THE ENDOSCOPY WAS UNEVENTFUL AND THEY WERE ABLE TO RETRIE

  Patient problems: Foreign Body In Patient

  MAUDE report 23297501 ↗
• MalfunctionJun 20, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED "THE SERIAL DILATOR PARTS FELL INSIDE OF THE PATIENT¿S STOMACH RATHER THAN PULLING ALL THE WAY OUT. THE PART THAT GETS PULLED OUT PRIOR TO PUSHING THE TUBE IN, FELL INTO THE STOMACH RATHER THAN BEING ABLE TO BE PULLED OUT." THE HEALTHCARE PROVIDER "ENDED UP RETRIEVING THE LEFTOVER PIECE ENDOSCOPICALLY." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22297329 ↗
• InjuryApr 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED VIA MEDWATCH UF REPORT 2201100000-2024-8004, THE HOSPITAL RECENTLY BEGAN USING AVANOS NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTOR. THIS BRAND OF DAYHOFF TUBE IS A NEWER PRODUCT FOR US. THE DESIGN OF THIS PRODUCT INCLUDES TWO LUMENS, THEREFORE ALLOWING TUBE FEEDS TO BE ADMINISTERED WITH THE GUIDEWIRE IN PLACE. THE PREVIOUS NASOGASTRIC TUBE USED BY THE HOSPITAL HAD A SINGLE LUMEN, AND THEREFORE IT WAS NOT POSSIBLE TO ADMINISTER TUBE FEEDS WITH THE GUIDEWIRE IN PLACE. THE HOSPITAL HAS HAD SOME ADVERSE AND NEAR-MISS EVENTS INVOLVING WHERE TUBE FEEDS WERE ADMINISTERED OR NEARLY ADMINISTERED WITH THE GUIDEWIRE STILL IN PLACE. WE HAVE COMMUNICATED WITH THE MANUFACTURER REGARDING THIS ISSUE. WE SUGGESTED THE PRODUCT INCLUDE A VISUAL CUE ON THE OUTSIDE OF THE TUBING TO INDICATE THAT THE GUIDEWIRE IS IN PLACE. WE ALSO RECOMMENDED THAT THE MANUFACTURER ADD A VISUAL CUE ON THE PROXIMAL END OF THE GUIDEWIRE TO STATE ¿REMOVE BEFORE FEEDING.¿¿ PER ADDITIONAL INFORMATION RECEIVED ON 22-MAR-2024, ¿THE REPORT WAS INTENDED TO ALERT YOU TO WHAT WE BELIEVE TO BE A PRODUCT DESIGN DEFECT. BECAUSE THE SIDE PORT CAN BE USED FOR FEEDS, IT HAS CREATED A FALSE SENSE OF READINESS TO USE IF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19024757 ↗
• MalfunctionFeb 6, 2024Difficult to Remove; Stretched; Obstruction of Flow; Difficult to Remove; Stretched; Obstruction of Flow

  IT WAS REPORTED THE "PATIENT HAD FEEDING TUBE IN PLACE APPROXIMATELY 3 WEEKS; IT WAS BEING REMOVED WHEN PATIENT REPORTED TUBE 'FELT STUCK' AND IT WAS DIFFICULT FOR STAFF TO PULL. PATIENT WAS TAKEN TO RADIOLOGY FOR GI TO REMOVE; WAS NOTED THAT TUBE HAD 'ANEURYSM IN THE DISTAL PORTION OF THE TUBE." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 17-JAN-2024 STATING THE "PATIENT WAS UNABLE TO FLUSH TUBE THAT HAD BEEN IN USE FOR 3 WEEKS. WHEN THE TUBE WAS REMOVED FOR REPLACEMENT, A BULGE WAS NOTED IN THE DISTAL PORTION. NO PATIENT INJURY, THE FEEDING TUBE HAD TO BE REPLACED VIA FLUOROSCOPY GUIDANCE." THE LOT NUMBER COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655620 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE HOME-CARE REGISTERED DIETITIAN (RD) SPOKE TO THE PATIENT WHO STATED, THEY HAD PREVIOUSLY NEEDED A GASTROSTOMY-JEJUNOSTOMY TUBE (GJ-TUBE) AND EXPERIENCED STOMACH CONTENTS LEAKING ONTO THEIR SKIN; A WOUND STARTED TO FORM. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THIS REPORT, INCLUDING THE BRAND OF THE TUBE AND IF ANY MEDICAL ATTENTION WAS PROVIDED. IT WAS ADDITIONALLY REPORTED, THE [CURRENT] NASOGASTRIC TUBE WAS PLACED ON (B)(6) 2022 AND THE PATIENT BEGAN THE PEPTIDE BASED FORMULA. THE FIRST REPORTED ALLERGIC REACTION WAS ON (B)(6) 2022, THE FORMULA WAS THEN CHANGED TO AN ELEMENTAL FORMULA. ON (B)(6) 2022, THE PATIENT REPORTED A CONTINUED ALLERGIC REACTION, AND THE FORMULA WAS CHANGED AGAIN, TO A DIFFERENT ELEMENTAL FORMULA. [AS A RESULT], THE PATIENT WAS TRIALED ON 3 DIFFERENT FORMULAS (PEPTIDE BASED, ELEMENTAL AND A SECOND ELEMENTAL FROM A DIFFERENT MANUFACTURER); ALL WITH THE SAME ¿ALLERGIC SYMPTOMS¿; THERE WAS NO REPORTED PROBLEM(S) WITH INCREASING THE FEEDING FORMULA TO GOAL RATE. THE PATIENT REPORTED, THEY USED SILICONE TAPE TO ADHERE THE TUBE TO THEIR CHEEK AND TUCKED IT OVER THEIR EAR, THE TAPE WAS IN PLACE FOR A DAY; AFTER THE TAPE WAS REMOVED,

  Patient problems: Itching Sensation; Rash; Skin Inflammation/ Irritation; Swollen Lymph Nodes/Glands

  MAUDE report 15846249 ↗