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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 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: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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Sources and updates

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