CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP 50-7366Recalls & reported problems
Avanos Medical, Inc. · CORFLO* PEG Jejunal Feeding Tube · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770462271), received between Aug 25, 2021 and Sep 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
- Stretched1
Patient problems
- Foreign Body In Patient3
- Adult Respiratory Distress Syndrome1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Break; Break
IT WAS REPORTED THE "THERE WAS AN ISSUE IDENTIFIED WITH THE J-TUBE BEING BLOCKED, ROUTINE ATTEMPTS MADE TO UNBLOCK THE TUBE. DURING A DIAPER CHANGE THE J-TUBE WAS FOUND TO BE PROTRUDING FROM THE RECTUM. J-TUBE WAS INSERTED (B)(6)." ADDITIONAL INFORMATION RECEIVED 15-AUG-2025, NO INJURY OCCURRED FROM THE INCIDENT. THE PATIENT WAS REQUIRED TO BE NPO [NOTHING BY MOUTH] AND HAVE A PERIPHERAL IV [INTRAVENOUS] INSERTED. THE PATIENT ALSO REQUIRED AN X-RAY AND TRIP TO IR [INTERVENTIONAL RADIOLOGY TO GET A NEW TUBE INSERTED. NO CHANGES TO CURRENT STATUS DUE TO THIS INCIDENT. PATIENT REMAINS IN STABLE CONDITION. THE PATIENT WAS ON CONTINUOUS FEEDS ONLY VIA THE NASOJEJUNAL [NJ. THE PATIENT WAS RECEIVING ENFAMIL-A AT 36ML/HR WHICH IS A STANDARD FEED THAT IS NOT CONCENTRATED. THE PATIENT WAS RECEIVING THE FOLLOWING MEDICATIONS WHICH INCLUDED VITAMIN D, OMEPRAZOLE AND IRON. ALL MEDICATIONS WERE LIQUID AND PREPARED BY PHARMACY. THE PATIENT ALSO WAS GIVEN ENZYMES TO UNBLOCK THE TUBE APPROXIMATELY EVERY THREE DAYS. NO STANDARD TUBE FLUSHES WERE ORDERED OR GIVEN, BUT THE PATIENT RECEIVED "FLUSHES POST EVERY MEDICATION ADMINISTRATION." THE FLUSHES WERE ADMINISTERED MANUALLY FOR MEDICATIONS, NORMALLY
Patient problems: Foreign Body In Patient
MAUDE report 23034347 ↗MalfunctionFeb 12, 2024Break; Stretched; Break; Stretched
PER ADDITIONAL INFORMATION RECEIVED ON 23-FEB-2024, ¿WHEN EXAMINING THE REMOVED TUBE, A PORTION OF THE TUBE REMAINED IN THE BODY, SPECIFICALLY IN THE LOWER ESOPHAGUS. THIS WAS CONFIRMED ON X-RAY WHICH SHOWED ONE TIP OF THE TUBE IN THE RIGHT UPPER QUADRANT AND THE OTHER LIKELY WITHIN THE MID ESOPHAGUS.¿
Patient problems: Adult Respiratory Distress Syndrome; Foreign Body In Patient
MAUDE report 18684176 ↗MalfunctionAug 25, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE WAS REMOVED VIA TRACTION AND THE INTERNAL BUMPER SEPARATED FROM THE PEG TUBE AND WAS RETAINED. THERE WAS A SPLIT IN THE TUBE CLOSE TO SKIN LEVEL. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REPORTED. THE DEVICE WAS INSERTED IN (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED 16-AUG-2021 INDICATED "ON TRACTION REMOVAL OF A PATIENT'S CORFLOPEG TUBE THE INTERNAL BUMPER SEPARATED FROM THE PEG TUBE AND WAS RETAINED IN THE STOMACH. PATIENT TO BE MONITORED FOR SIGNS OF OBSTRUCTION AND IF EXPERIENCES ANY ABDOMINAL PAIN, ABDOMINAL DISTENTION, NAUSEA, VOMITING, ALTERED BOWEL HABITS TO ARRANGE AN URGENT MEDICAL/HOSPITAL REVIEW.'" ADDITIONAL INFORMATION RECEIVED 17-AUG-2021 INDICATED "DURING REMOVAL OF PEG TUBE, INTERNAL BUMPER CAME DETACHED FROM PEG TUBE AND WAS RETAINED IN PATIENT." FURTHER ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Foreign Body In Patient
MAUDE report 12367136 ↗
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
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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