AVANOS 40-7431Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00350770460321), received between Feb 10, 2023 and Sep 25, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Entrapment of Device

  A potential human factors/design concern: A Dobhoff (CORFLO Enteral Feeding Tube) was inserted overnight with the stylet left in place following insertion. It is unknown whether the retained stylet was recognized during subsequent nursing assessments. The issue was identified the following day when the patient underwent an MRI examination.After completion of the scout image and first imaging sequence, MRI technologists noted image artifact and questioned whether the patient had any metal associated with the feeding tube. An additional sequence was attempted; however, due to continued artifact, the patient was slowly removed from the scanner for further assessment. The patient denied having any implanted facial metal or other metallic objects.The MRI team asked the patient's nurse to inspect the feeding tube. Upon examination, the nurse discovered that the stylet remained in the Dobhoff tube. The stylet was immediately removed and discarded in a sharps container. The patient had been in the MRI scanner approximately 3 to 5 minutes before the retained stylet was identified. The radiologist was notified and confirmed that imaging could proceed following stylet removal.The patient repo

  Patient problems: Foreign Body In Patient

  MAUDE report 50896933 ↗
• MalfunctionJul 27, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034975 ↗
• MalfunctionJul 14, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812228 ↗
• MalfunctionJul 14, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812212 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NASOGASTRIC TUBE LEAKED OUTSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081155 ↗
• MalfunctionApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA (B)(4) FDA MEDWATCH / FDA USER FACILITY REPORTS THE FOLLOWING INFORMATION WAS PROVIDED: "CORFLO NG [NASOGASTRIC] TUBING WITH GUIDEWIRE STYLETS LEFT POST NG PLACEMENT. PROCEDURE IS TO PLACE THE TUBE USING THE GUIDEWIRE, SEND PATIENTS TO X-RAY TO CONFIRM PLACEMENT, THEN REMOVE STYLET BEFORE USING THE TUBE. THE TUBE WAS UTILIZED FOR FEEDINGS/MEDS FOR SEVERAL DAYS BEFORE REALIZING THE GUIDEWIRE REMAINED. BECAUSE THE STYLET AND THE PORTS ARE THE SAME COLOR, NURSING WAS NOT ALERTED TO THE FACT THAT THE STYLET HAD NOT BEEN REMOVED POST IMAGING. DESIGN FLAW. REMOVE THE STYLET AFTER CONFIRMING PLACEMENT. DEVICE WAS HARD TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988087 ↗
• MalfunctionApr 17, 2026Complete Blockage

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00231 FOR THE FIRST REPORT. IT WAS REPORTED THAT TWO PROBES CLOGGED REGULARLY. THEY GET RINSED EVERY HOUR WITH 30ML OF WATER AND AT THE END OF NUTRITION WITH 60ML OF COLD WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911683 ↗
• MalfunctionApr 17, 2026Complete Blockage

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE DIFFERENT PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER FOR THE FIRST REPORT REFER TO 9611594-2026-00232 FOR THE SECOND REPORT IT WAS REPORTED THAT TWO PROBES CLOGGED REGULARLY. THEY GET RINSED EVERY HOUR WITH 30ML OF WATER AND AT THE END OF NUTRITION WITH 60ML OF COLD WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911679 ↗
• MalfunctionMar 26, 2026

  CORFLOW NG [NASOGASTRIC] TUBING WITH GUIDEWIRE STYLETS LEFT POST NG PLACEMENT. PROCEDURE IS TO PLACE THE TUBE USING THE GUIDEWIRE, SEND PATIENTS TO X-RAY TO CONFIRM PLACEMENT, THEN REMOVE STYLET BEFORE USING THE TUBE. THE TUBE WAS UTILIZED FOR FEEDINGS/MEDS FOR SEVERAL DAYS BEFORE REALIZING THE GUIDEWIRE REMAINED. BECAUSE THE STYLET AND THE PORTS ARE THE SAME COLOR, NURSING WAS NOT ALERTED TO THE FACT THAT THE STYLET HAD NOT BEEN REMOVED POST IMAGING. DESIGN FLAW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698415 ↗
• MalfunctionMar 26, 2026

  CORFLOW NG TUBING WITH GUIDEWIRE STYLETS LEFT POST NG PLACEMENT. PROCEDURE IS TO PLACE THE TUBE USING THE GUIDEWIRE, SEND PATIENTS TO X-RAY TO CONFIRM PLACEMENT, THEN REMOVE STYLET BEFORE USING THE TUBE. THE TUBE WAS UTILIZED FOR FEEDINGS/MEDS FOR SEVERAL DAYS BEFORE REALIZING THE GUIDEWIRE REMAINED. BECAUSE THE STYLET AND THE PORTS ARE THE SAME COLOR, NURSING WAS NOT ALERTED TO THE FACT THAT THE STYLET HAD NOT BEEN REMOVED POST IMAGING. DESIGN FLAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698414 ↗
• MalfunctionDec 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, ¿FOUND WITHOUT THE TIP OF THE PROBE. PLASTIC SEVERED IN THE MIDDLE OF THE PROBE."

  Patient problems: Insufficient Information

  MAUDE report 23882490 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THERE WAS A HOLE IN THE TUBE. THE HOLE WAS AT "THE 60 CM MARK." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22523795 ↗
• MalfunctionMay 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THERE WAS SPILT ON THE NASOGASTRIC TUBE AT THE 60CM MARK "IT WAS ADJACENT TO THE BRIDLE." ADDITIONAL INFORMATION RECEIVED 22-APR-2025 STATING "DAMAGE WAS NOTICED AT THE 60 CM MARKING. THE TUBE WAS PLACED ON (B)(6) 2025 AND THE ISSUE WAS NOTICED ON APRIL 14TH. PATIENT COMPLAINED OF FEELING WATER DRIPPING DOWN UNDER HIS NOSE OVER HIS TOP LIP. NO CLOGGING OR BLOCKAGE NOTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978661 ↗
• MalfunctionMay 6, 2025Stretched; Stretched

  IT WAS REPORTED, ¿PROBE INSTALLED ON (B)(6) 2025. THE PATIENT COMPLAINS OF SIGNIFICANT DISCOMFORT. DIFFICULTY REMOVING CATHETER ON (B)(6) 2025. PRESENCE OF AN INCOMPRESSIBLE HERNIA APPROXIMATELY 2CM IN DIAMETER AT THE 36CM MARK ON THE PROBE. CONSEQUENCES FOR THE PATIENT: SIGNIFICANT DISCOMFORT WITH THE PROBE, DIFFICULTY SWALLOWING AND BREATHING. CHANGE OF DEVICE.¿ PER ADDITIONAL INFORMATION RECEIVED ON 15APR2025, THE HERNIA IS REFERENCING A PORTION OF THE NASOGASTRIC TUBE THAT BALLOONED. THE TUBE WAS REMOVED WITH DIFFICULTY BUT WITHOUT SURGERY. THE PATIENT IS BETTER NOW THAT A NEW TUBE IS IN PLACE.

  Patient problems: Dysphagia/ Odynophagia; Dyspnea

  MAUDE report 21970584 ↗
• MalfunctionApr 14, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 0504540000-2023-8008 THE FOLLOWING INFORMATION: FEEDING TUBE (NASAL GASTRIC TUBE) CLOGGED, DAY SHIFT RN USED CLOG BUSTER AND SMALL SYRINGE. TUBE FUNCTIONAL AGAIN BY NIGHT SHIFT, TUBE FEEDING HUNG. NEXT DAY, FEEDING STOPPED (INTERMITTENT FEEDING AT NIGHT) AND FLUSHED. 2 HOURS LATER MEDS ATTEMPTED TO BE GIVEN VIA FT, BUT IT WAS AGAIN CLOGGED. RN ATTEMPTED TO UNCLOG WITH WARM WATER AND 5CC SYRINGE, AND THEN CLOG ZAPPER(AVANOS) WAS USED BY RESOURCE RN WHEN THAT WAS UNSUCCESSFUL. AFTER CLOG ZAPPER, RN WAS ABLE TO FLUSH WITH 5CC SYRINGE. WHEN ATTEMPT MADE TO FLUSH WITH 60 CC SYRINGE, WATER CAME OUT PATIENT'S NOSE. TEAM MADE AWARE OF ABOVE EVENTS AND SUSPECTED BROKEN TUBE. TUBE WAS REMOVED PER ORDER AND WAS INDEED BROKEN. ENT CONSULTED BY PRIMARY TEAM, WHO WAS ABLE TO REMOVE REMAINING PORTION OF FT. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743761 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED "THE [PATIENT] VOMITED UP THE OPPOSITE END (BASE END), STAFF HAD TO REMOVE THE SECTION THAT WAS STILL IN PLACE THROUGH THE NASAL CAVITY WHICH MEASURE ABOUT 94CM WAS STILL IN SITU. THE MAIN CONCERN IS THIS TUBE FRACTURED WHILE IN PLACE ¿ INTERNALLY. THE [PATIENT] DID NOT EXPEL THE END WHICH MEASURES ABOUT 15CM LONG." THE DEVICE WAS IN USE FOR 58-DAYS. MEDICAL TREATMENT IS DESCRIBED AS "RE-INSERTION OF NEW TUBE." PATIENT'S CURRENT HEALTH STATUS IS STABLE. THE NASOGASTRIC TUBE WAS INSERTED ON (B)(6) 2022 ON THE (B)(6) HOSPITAL UNIT. THE PATIENT WAS TRANSFERRED TO (B)(6) AND THEN TO (B)(6) FOR TRANSPLANT ASSESSMENT AND RETURNED TO (B)(6) ON (B)(6) 2022. DURING THAT STAY ON (B)(6) 2022 DOCUMENTATION STATED "INSERT TRANSPYLORIC TUBE (TPT) 4CM MORE." THE PATIENT TRANSFERRED TO (B)(6) HOSPITAL UNIT ON (B)(6) 2022 WITH TPT DOCUMENTED IN PLACE AT THAT TIME. THE PATIENT WAS RECEIVING CONTINUOUS FEEDS VIA TPT OF MONOGEN (30.2%) + BENEPROTEIN (10%) @ 36ML/HR. THE FEEDS RAN 15-HOURS TO 24-HOURS WHEN THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL UNIT. THE PATIENT WAS ALSO RECEIVING MEDICATIONS VIA TPT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16352921 ↗