AVANOS 20-9551Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00350770458137), received between Jul 16, 2020 and Aug 11, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Leak/Splash; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204515 ↗
• MalfunctionJul 14, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812190 ↗
• MalfunctionJul 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812185 ↗
• MalfunctionJul 1, 2026Material Puncture/Hole

  IT WAS REPORTED "IMMEDIATELY AFTER THE PATIENT'S CATHETER PLACEMENT WAS COMPLETED, THE NUTRIENT SOLUTION WAS DELIVERED. IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE NUTRITION TUBE, AND THE NUTRIENT SOLUTION LEAKED OUT. THEN A NEW GASTROINTESTINAL FEEDING TUBE WAS REPLACED AND THE PATIENT WAS RE-CANNULATED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682707 ↗
• MalfunctionJul 1, 2026Material Rupture

  IT WAS REPORTED THE NASOGASTRIC TUBE "BURST OCCURRED ON OUTSIDE OF PATIENT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682703 ↗
• MalfunctionJul 1, 2026Material Rupture

  THE CUSTOMER REPORTED THAT AFTER APPROXIMATELY 7 DAYS OF USE, THE FEEDING TUBE RUPTURED EXTERNALLY TO THE PATIENT AND REQUIRED REPLACEMENT. NO ADDITIONAL MEDICAL TREATMENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25682683 ↗
• MalfunctionMay 28, 2026Connection Problem

  THE CUSTOMER REPORTED THAT A NASOGASTRIC TUBE COULD NOT BE PROPERLY CONNECTED DURING USE IN THE ICU. THE CONDITION WAS REPORTEDLY IDENTIFIED AFTER APPROXIMATELY SIX DAYS OF USE. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REPORTED; HOWEVER, THE TUBE WAS REPLACED WITH A NEW TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315421 ↗
• MalfunctionMay 28, 2026Leak/Splash

  THE CUSTOMER REPORTED THAT A NASOGASTRIC LEAKED LIQUID DURING USE IN THE INTENSIVE CARE UNIT. THE LEAKAGE CONDITION WAS REPORTEDLY IDENTIFIED AFTER APPROXIMATELY TWO DAYS OF USE. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REPORTED; HOWEVER, THE TUBE WAS REPLACED WITH A NEW TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315414 ↗
• MalfunctionMar 31, 2026Break; Complete Blockage

  IT WAS REPORTED THERE WAS AN "INCIDENT WHERE A CORTRAK TUBE WAS CLOGGED AND IN THE UNCLOGGING PROCESS THE TUBE BROKE, RESULTING IN A LARGE SECTION OF RETAINED TUBE THAT REQUIRED AN [ESOPHAGOGASTRODUODENOSCOPY] EGD FOR RETRIEVAL. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24743468 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED, ¿DEVICE FRAGMENTS FOUND IN PATIENT'S BODY. THE PATIENT WAS HOSPITALIZED FOR A LONG TIME AND WAS IN A CHRONIC CRITICAL CONDITION REQUIRING POSTPYLORIC FEEDING VIA JEJUNAL TUBE. THE PRODUCT HAD A SHELF LIFE OF 3 MONTHS. ON THE 88TH DAY OF USE, THE DOCTOR ORDERED A REPLACEMENT OF THE JEJUNAL TUBE. UPON REMOVAL OF THE JEJUNAL TUBE, A BROKEN TUBE WAS DISCOVERED. THE BEDSIDE NURSE IMMEDIATELY REPORTED TO THE ATTENDING PHYSICIAN. AN ABDOMINAL X-RAY REVEALED THE BROKEN TUBE IN THE RIGHT LOWER ABDOMEN. THE DOCTOR CONSULTED WITH THE GASTROENTEROLOGY DEPARTMENT, AND THE BROKEN TUBE WAS REMOVED ENDOSCOPICALLY. THE PATIENT'S VITAL SIGNS ARE CURRENTLY STABLE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489568 ↗
• MalfunctionFeb 17, 2026Material Separation

  IT WAS REPORTED "THE PIPELINE AND ACCESSORIES ARE FOUND TO BE SEPARATED, AND THE SUSPECTED PRODUCT REASON IS THE INITIAL TREATMENT SITUATION: ALTHOUGH IT IS IN A SEPARATED STATE, IT CAN STILL BE USED AFTER BEING INSERTED, AND IT IS NOT VERY FIRM. SINCE THE GASTROINTESTINAL NUTRITION TUBE HAS JUST BEEN IMPLANTED IN THE BODY, RE-INSERTION OF THE TUBE WILL INCREASE THE PATIENT'S PAIN. SINCE IT CAN BE USED, IT WILL BE CONTINUED AFTER CONSULTATION WITH THE PATIENT'S FAMILY. ADDITIONAL INFORMATION RECEIVED 18-JAN-2026 NOTED THE TUBE HAS SEPARATED FROM THE CONNECTION KIT. THE FITTING CONNECTED TO THE YELLOW HOSE. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369458 ↗
• MalfunctionNov 26, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THE PATIENT HAD A "GASTROINTESTINAL FEEDING TUBE INSERTED ON (B)(6) 2025. ON (B)(6) AT 10:50 AM, THE PATIENT EXPERIENCED DIFFICULTY FEEDING THROUGH THE NASOENTERIC TUBE. THE TUBE WAS REMOVED, AND IT WAS FOUND THAT THE TUBE WALL WAS THINNED, AND THE MIDDLE SECTION OF THE TUBE EXPERIENCED AIR INFLATING, CAUSING FOLDING AND BLOCKAGE. THE TUBE HAD ONLY BEEN USED FOR 7- DAYS...REINSERTION AFTER REMOVAL CAUSED PAIN AND HARM TO THE PATIENT." THERE WAS NO REPORTED INJURY.

  Patient problems: Feeding Problem

  MAUDE report 23661043 ↗
• MalfunctionNov 19, 2025Complete Blockage; Malposition of Device; Complete Blockage; Malposition of Device

  IT WAS REPORTED "THE TUBE IS UNOBSTRUCTED BUT THERE IS RESISTANCE. WHEN NASOGASTRIC FEEDING IS FLUSHED, THE TUBE WALL AT THE NOSE PATCH SUDDENLY BULGES LIKE A BALLOON. PATIENT RECEIVING LONG-TERM NASOGASTRIC NUTRITION AND A LONG-TERM INDWELLING NASOGASTRIC FEEDING TUBE. THE ORIGINAL NASOGASTRIC TUBE WAS REPLACED UPON EXPIRATION ON (B)(6) 2025 AND WAS USED FOR 15-DAYS UNTIL (B)(6) 2025. AFTER ADMINISTERING MEDICATION IN THE AFTERNOON, RESISTANCE TO THE TUBE LUMEN WAS SUSPECTED DURING THE NASOGASTRIC FEEDING PROCEDURE. A 20ML SYRINGE WAS USED TO FLUSH THE TUBE. WHEN APPLYING WARM WATER WITH SLIGHT PRESSURE, THE TUBE WALL AT THE NOSE PATCH SUDDENLY BULGED, RESEMBLING A BALLOON. THE DOCTOR WAS INFORMED AND THE TUBE WAS REMOVED AND REPLACED. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT" THE PROCESS TO REPLACE THE TUBE "WENT SMOOTHLY, AND AN X-RAY HAS BEEN TAKEN TO CONFIRM THAT THE TUBE IS IN PLACE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601046 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THERE WAS A "RUPTURE OF THE NASOGASTRIC TUBE 60 CM PROXIMAL TO THE TIP (INSIDE THE STOMACH) ...THE PATIENT WAS SUFFERING FROM UREMIA AND A LUNG INFECTION. [THE PATIENT] WAS CONNECTED TO A VENTILATOR AT [THE PATIENT'S] TRACHEOSTOMY, BEDRIDDEN FOR A LONG TIME, COMATOSE, AND HAD POOR GASTRIC MOTILITY. TO PREVENT ASPIRATION, [THE PATIENT'S] REQUIRED LONG-TERM POST-PYLORIC FEEDING AND A LONG-TERM INDWELLING NASOGASTRIC TUBE. ON (B)(6) 2025, THE NASOGASTRIC TUBE WAS REPLACED WITH A 100CM LONG TUBE. BEDSIDE RADIOGRAPHS CONFIRMED THAT THE TUBE WAS IN THE INTESTINE. NUTRITIONAL FLUIDS WERE BEING FED THROUGH THE NASOGASTRIC TUBE FOR 85-DAYS. ON (B)(6) 2025, THE NASOGASTRIC TUBE WAS REMOVED AND A SEVERE RUPTURE WAS DISCOVERED NEAR THE 60CM MARK (INSIDE THE STOMACH). THE INTEGRITY OF THE TUBE WAS RECHECKED, AND THE DOCTOR AND HEAD NURSE WERE NOTIFIED. A NEW NASOGASTRIC TUBE WAS THEN REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601044 ↗
• MalfunctionNov 19, 2025Partial Blockage; Fracture; Partial Blockage; Fracture

  IT WAS REPORTED THE PATIENT HAS DIFFICULTY BREATHING; REPLACING THE NEW NASOINTESTINAL TUBE WILL CAUSE HARM TO THE ELDERLY PATIENT AND INCREASE THE RISK OF INFECTION. THE PATIENT SUFFERED FROM BRAIN TRAUMA AND LUNG INFECTION, WAS CONNECTED TO A VENTILATOR AT THE TRACHEOSTOMY SITE, AND WAS BEDRIDDEN FOR A LONG TIME. THE PATIENT WAS MENTALLY CONFUSED AND HAD POOR GASTRIC MOTILITY. TO PREVENT ASPIRATION, THE PATIENT REQUIRED LONG-TERM POST-PYLORIC FEEDING AND A LONG-TERM INDWELLING NASOGASTRIC TUBE. ON (B)(6) 2025, THIS NASOGASTRIC TUBE WAS REPLACED. THE TUBE, WITH AN INTERNAL LENGTH OF 110 CM, WAS LATER CONFIRMED TO BE IN THE INTESTINE BY BEDSIDE RADIOGRAPHY. NUTRITIONAL FLUIDS WERE BEING FED THROUGH THE NASOGASTRIC TUBE FOR 17-DAYS. ON (B)(6) 2025, THE PATIENT WAS FOUND TO BE DYSPNEIC. EXAMINATION REVEALED A BULBOUS BULGE AT THE CONNECTOR TIP OF THE NASOENTERIC FEEDING TUBE, AN INTERNAL FRACTURE, AND A MEMBRANE COVERING THE OUTER SURFACE. CHECKED THE INTEGRITY OF THE CATHETER AGAIN; REPORT TO THE DOCTOR AND THE HEAD NURSE AND REPLACED THE NASOGASTRIC TUBE.

  Patient problems: Dyspnea

  MAUDE report 23601042 ↗
• InjuryOct 9, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PNEUMOTHORAX EVENT OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 23257962 ↗
• MalfunctionOct 6, 2025Fluid/Blood Leak; Material Puncture/Hole; Malposition of Device; Fluid/Blood Leak; Material Puncture/Hole; Malposition of Device

  IT WAS REPORTED " ON (B)(6) 2025, THE PATIENT RETURNED TO THE WARD AT 8:30 AM AFTER THE NASOENTERIC TUBE WAS REPLACED IN THE GASTROSCOPY ROOM. THE GASTROSCOPY REPORT SHOWED THAT UNDER THE DIRECT GUIDANCE OF THE GASTROSCOPE, THE NASOJEJUNAL NUTRITION TUBE WAS PLACED IN THE DESCENDING DUODENUM, WITH AN INSERTION DEPTH OF APPROXIMATELY 120 CM FROM THE INCISORS. RETURNING TO THE WARD TO CHECK THE NASOINTESTINAL TUBE SCALE OF 116CM, THE PATIENT OPENED HIS MOUTH AND FOUND THAT PART OF THE INTESTINAL TUBE WAS COILED IN HIS MOUTH. [IT WAS] REPORTED TO THE DOCTOR AND CALLED THE GASTROSCOPY ROOM OPERATING PHYSICIAN. [CLINICIAN] FOLLOWED THE INSTRUCTIONS TO PULL OUT THE COILED PART AND INSERTED IT AT A DEPTH OF ABOUT 100CM FROM THE TIP OF THE NOSE. [THE PATIENT] TRIED NASOGASTRIC FEEDING WITH WARM WATER. THE PATIENT HAD A SLIGHT COUGH REACTION. AFTER REPORTING TO THE DOCTOR, [CLINICIAN] WAS GIVEN NASOGASTRIC FEEDING OF RUIDAI NUTRIENT SOLUTION AT 10:00. AT 10:20, [THE PATIENT] WAS FOUND TO HAVE COUGHED AND EXPECTORATED. SOME SPUTUM COULD BE COUGHED OUT FROM THE TRACHEOTOMY. THE SPUTUM WAS YELLOW WHITE. IT WAS SUSPECTED THAT THE NUTRIENT SOLUTION WAS ASPIRATED, SO NASOGASTRIC FEEDING WAS SUSPE

  Patient problems: Aspiration/Inhalation; Cough

  MAUDE report 23227976 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THE "ENTERAL NUTRITION WAS PUMPED INTO THE PATIENT AT 40-60ML/H. THE PATIENT WAS FOUND TO HAVE [A] DEVICE RETENTION. GASTROINTESTINAL DECOMPRESSION WAS IMMEDIATELY PERFORMED AND [A PHYSICIAN" EXAMINATION WAS PERFORMED TO FIND THAT THE TUBE MAY BE BROKEN IN THE BODY." DURING THE GASTROINTESTINAL EXAMINATION IT WAS NOTED "IF THE GASTROINTESTINAL TUBE IS BROKEN," THE GASTROENTEROLOGIST WAS TO "REMOVE THE BROKEN NUTRITION TUBE UNDER GASTROSCOPY AND RE-INDWELL THE GASTROINTESTINAL NUTRITION TUBE." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22815118 ↗
• MalfunctionFeb 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED AT 7:00 ON (B)(6) "THE INTESTINAL TUBE WAS FOUND TO BE BLOCKED DURING NASOGASTRIC FEEDING AND THE TUBE WAS FLUSHED WITH WARM WATER. THE INTESTINAL TUBE WAS RUPTURED DURING THE FLUSHING, AND THE RUPTURE POSITION WAS MARKED AT 60 CM ON THE TUBE BODY. THE PATIENT'S NASOGASTRIC TUBE WAS REMOVED AND A NEW NASOGASTRIC TUBE WAS INSERTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349613 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED "THE NURSE PERFORMED A PRE-NASOGASTRIC TUBE ASSESSMENT ACCORDING TO THE NORMAL OPERATING PROCEDURES AND FOUND THAT THE HEAD END OF THE PATIENT'S JEJUNAL TUBE WAS RUPTURED. THE [INCIDENT] WAS REPORTED TO THE DOCTOR, WHO REMOVED THE JEJUNAL TUBE AND FOUND THAT THE MIDDLE OF THE JEJUNAL TUBE WAS BROKEN. IMMEDIATELY ACCOMPANIED BY MEDICAL STAFF, AN ABDOMINAL PLAIN FILM EXAMINATION WAS PERFORMED. AFTER THE EXAMINATION, IT WAS FOUND THAT THE MIDDLE OF THE JEJUNAL TUBE WAS ABOUT 50CM LONG AND WAS BROKEN IN THE PATIENT'S STOMACH. THE JEJUNAL TUBE WAS PLACED ON (B)(6) 2024...AFTER THE FAMILY MEMBERS SIGNED AND AGREED, THE JEJUNAL TUBE SEGMENT STUMP OF ABOUT 50CM WAS IMMEDIATELY REMOVED UNDER EMERGENCY ENDOSCOPY ACCOMPANIED BY MEDICAL STAFF. THE PROCESS WENT SMOOTHLY." THE DEVICE WAS REPLACED FOR ANOTHER DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20187029 ↗
• MalfunctionMay 13, 2024Complete Blockage; Material Puncture/Hole; Complete Blockage; Material Puncture/Hole

  IT WAS REPORTED THE NASOGASTRIC (NG) "TUBE BLOCKED, FLUSHED, THEN RUPTURED AT 60CM ON TUBE BODY. PAIN INCREASED...NG TUBE REMOVED AND REPLACED WITH ANOTHER FEEDING TUBE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298830 ↗
• MalfunctionFeb 16, 2024Break; Stretched; Obstruction of Flow; Break; Stretched; Obstruction of Flow

  ADDITIONAL INFORMATION RECEIVED 19-MAR-2024 NOTED THE TUBE BURST INSIDE THE PATIENT AFTER 16-DAYS IN USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18726909 ↗
• MalfunctionDec 20, 2023Crack; Crack

  IT WAS REPORTED, "THE PATIENT HAD REFLUX, AND THE JEJUNAL NUTRITION TUBE WAS REPLACED. WHEN THE TUBE WAS REMOVED, IT WAS FOUND THAT THE NUTRITION TUBE WAS PARTIALLY CRACKED." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369382 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED "THE PRODUCT BROKE DURING USE ON (B)(6) 2022 AND HALF OF IT WAS LEFT IN THE INTESTINE. AFTER MULTI-DEPARTMENT CONSULTATION IN THE WHOLE HOSPITAL, THERE WAS NO SOLUTION." THREE DAYS LATER, THE PATIENT EXPELLED THE BROKEN DEVICE. THE PATIENT WAS IN "GOOD CONDITION."

  Patient problems: Foreign Body In Patient

  MAUDE report 16956067 ↗
• MalfunctionApr 11, 2023Material Rupture; Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2023-00049 FOR THE FIRST EVENT. REFER TO 9611594-2023-00050 FOR THE SECOND EVENT. REFER TO 9611594-2023-00051 FOR THE THIRD EVENT. IT WAS REPORTED THE NASOGASTRIC TUBE BURSTING DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16719238 ↗