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AVANOS 42-9226Recalls & reported problems

Avanos Medical, Inc. · CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit® Connector · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00350770460864), received between Sep 10, 2020 and Apr 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 3 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break6
  • Material Split, Cut or Torn3
  • Stretched2
  • Complete Blockage1
  • Material Puncture/Hole1
  • Material Rupture1
  • Obstruction of Flow1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Foreign Body In Patient3
  • Discomfort1
  • Insufficient Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 28, 2026Break

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00255 FOR THE FIRST EVENT. IT WAS REPORTED "THE COMMUNITY NURSE SUPPORTING THE NG CHANGE ADVISED THE END ON THE REPLACEMENT TUBE WAS ALSO BROKEN." THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25021864 ↗
  • MalfunctionApr 28, 2026Break

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00256 FOR THE SECOND EVENT. IT WAS REPORTED "THE PATIENT HAD A TUBE IN PLACE, BUT THE END HAD BROKEN. THE TUBE WAS IN SITU FOR 2.5 MONTHS AND WAS DUE TO BE CHANGED. A NEW TUBE WAS INSERTED (SAME BATCH)." THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25021861 ↗
  • MalfunctionApr 22, 2026Material Puncture/Hole

    IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE FOUND TO HAVE SEVEN SMALL HOLES AROUND THE TOP OF THE TUBE. THE NG TUBE HAD BEEN INSERTED, THE GUIDEWIRE REMOVED, BUT THEY WERE UNABLE TO ASPIRATE. THE HOLES WERE NOTED ON FURTHER INSPECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24954947 ↗
  • MalfunctionNov 8, 2024Break; Break

    PER ADDITIONAL INFORMATION RECEIVED ON 20NOV2024, ¿THE DOCTOR EXPLAINED US THAT THE TUBE WAS NOT THE CAUSE. THE BABY WAS A VERY CRITICAL PATIENT FOR DIFFERENT PATHOLOGIES AND THESE PATHOLOGIES WERE THE CAUSE OF DEATH. IN FACT, THE DOCTOR PLACED A NEW TUBE AFTER THE REMOVAL OF THE BROKEN TUBE WITHOUT ANY PROBLEM.¿

    Patient problems: Foreign Body In Patient

    MAUDE report 20646155 ↗
  • MalfunctionOct 16, 2024Break; Break

    IT WAS REPORTED, BROKEN NASOGASTRIC TUBE. THE PATIENT IS STABLE, WITHOUT ANY NEGATIVE CONSEQUENCE AND ANY INTERVENTION NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20466732 ↗
  • MalfunctionSep 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED, THE 6FR CORFLO FEED TUBE HAD A HOLE IN IT (IN AN UNSPECIFIED LOCATION); THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 09AUG2023 REPORTED, THE HOLE WAS NOTED AFTER THE NASOGASTRIC (NG) TUBE HAD BEEN INSERTED INTO THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 11AUG2023 REPORTED, THE TUBE WAS INSERTED INTO THE PATIENT, AND THEY REALIZED THE ¿RATES¿ WEREN¿T RIGHT AND THE TUBE WAS REMOVED. UPON REMOVAL, THE HOLE WAS NOTICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 14AUG2023 REPORTED, A NEW TUBE WAS INSERTED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THE PATIENT WAS REPORTEDLY STABLE AND NO LONGER REQUIRED AN NG TUBE.

    Patient problems: Insufficient Information

    MAUDE report 17669373 ↗
  • MalfunctionMay 25, 2023Complete Blockage; Stretched; Material Split, Cut or Torn; Complete Blockage; Stretched; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE CORFLO NASOGASTRIC/ NASOINTESTINAL FEEDING TUBE WAS PLACED NASOJEJUNALLY. THE TUBE HAD BEEN IN APPROXIMATELY SIX MONTHS AND HAD BEEN DIFFICULT TO FLUSH NOT LONG BEFORE THE INCIDENT; THE DAUGHTER HAD FELT UNCOMFORTABLE. THEY HAD MANAGED TO REMOVE THE BLOCKAGE. AS THE TUBE HAD BEEN IN FOR SIX MONTHS ¿ THE PARENTS WERE ADVISED TO HAVE THE TUBE REPLACED. ON REMOVAL OF THE NASOJEJUNAL (NJ), THE TUBE SPLIT, LEAVING A CONSIDERABLE AMOUNT WITHIN THE PATIENT. THEY WERE THEN TRANSFERRED TO THE HOSPITAL FOR ENDOSCOPY UNDER ANESTHETIC TO REMOVE THE REMAINING TUBE. NO INJURY REPORTED. THE PATIENT WAS DISCHARGED HOME.

    Patient problems: Discomfort; Foreign Body In Patient

    MAUDE report 17004075 ↗
  • MalfunctionNov 22, 2022Break; Obstruction of Flow; Break; Obstruction of Flow

    IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO CONTINUOUS FEED VIA THE NASOJEJUNAL TUBE, AND THE PUMP SHOWED OCCLUSION. UNABLE TO FLUSH TUBE WITH ONE MILLILITER (ML) OF WATER DUE TO RESISTANCE. THE FLOW OF FLUID WAS THEN NOTED THROUGH THE TUBE. ANOTHER ATTEMPT WAS MADE TO FLUSH THE TUBE AND WAS SUCCESSFUL, WITHOUT RESISTANCE. THE PATIENT WAS NOTED TO HAVE MILK IN THE STOMACH A FEW HOURS LATER. XRAY WAS PERFORMED, WHICH SHOWED THE TUBE HAD SNAPPED. THE UPPER HALF WAS REMOVED. THE LOWER HALF WAS REMOVED ENDOSCOPICALLY UNDER GENERAL ANESTHESIA. THE PATIENT IS STABLE. NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15847359 ↗
  • MalfunctionOct 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE NASOGASTRIC TUBE HAS SPLIT. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10720782 ↗
  • MalfunctionSep 10, 2020Break; Material Rupture; Stretched; Break; Material Rupture; Stretched

    ADDITIONAL INFORMATION RECEIVED 17-SEP-2020 INDICATED INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN TUBE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CONDITION. ADDITIONAL INFORMATION RECEIVED 22-SEP-2020 INDICATED THE DISTAL END OF THE TUBE WAS RETRIEVED FROM THE INFANT SURGICALLY ON (B)(6) 2020.

    Patient problems: Foreign Body In Patient

    MAUDE report 10513617 ↗

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

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