AVANOS 40-4438Recalls & reported problems
Avanos Medical, Inc. · CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit® Connector · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770460215), received between Apr 7, 2022 and Mar 18, 2026 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Break
IT WAS REPORTED THE "PATIENT PULLED OUT THE FEEDING TUBE AND UPON INSPECTION OF TUBE, THE WEIGHT ON THE END WAS FOUND TO BE MISSING AND THE END OF THE TUBE WAS TORN, X-RAY BEING DONE TO FIND WHERE WEIGHT IS WITHIN PATIENT." THERE WAS NO REPORTED INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 24630370 ↗MalfunctionApr 7, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE NASOGASTRIC (NG) WAS CONFIRMED TO HAVE BROKEN INTO TWO PIECES VIA X-RAY. ENDOSCOPY WAS REQUIRED TO REMOVE A 25CM FRAGMENT OF TUBE FROM THE PATIENT. THE REPORTER ALLEGED THAT IT APPEARED AS IF SOME SORT OF ANEURYSM RUPTURE OCCURRED CAUSING THE TUBE TO BREAK. THE PATIENT WAS RECEIVING MEDICATION VIA THE TUBE FOUR TIMES A DAY FOLLOWING BY A 100ML WATER FLUSH VIA THE KANGAROO PUMP. THE NG TUBE HAD BEEN PLACED ON (B)(6) 2022 AND HAD BEEN IN USE FOR 13 DAYS PRIOR TO THE EVENT. PER ADDITIONAL INFORMATION RECEIVED ON 15 MAR 2022, THE REPORTER CONFIRMED THAT WHEN THE TUBE WAS INITIALLY PLACED, THE TUBE WAS FLUSHED WITH 10ML OF WATER VIA THE SIDE PORT PRIOR TO THE STYLET BEING REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 14046136 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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