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CORFLO Ultra Lite NG Small Bowel Feeding Tube 20-9551Recalls & reported problems

Corpak Medsystems, Inc. · Feeding tube, non weighted, with stylet · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10815149023561), received between Jan 11, 2017 and Dec 21, 2017 — classified as 1 injury, 2 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.

Most reported problems

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Device Embedded In Tissue or Plaque2
  • Bowel Perforation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2017Break; Break

    IT WAS REPORTED VIA THE DISTRIBUTOR THAT THE FEEDING TUBE WAS REMOVED ON 22 NOV 2017 AND IT WAS NOTED THAT APPROXIMATELY (B)(6) WAS MISSING FROM THE DISTAL END OF THE TUBE. THE TUBE HAD BEEN PLACED (B)(6) 2017. NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7137378 ↗
  • MalfunctionDec 20, 2017Break; Break

    IT WAS REPORTED VIA THE DISTRIBUTOR THAT DURING USE OF THE DEVICE, AN ABDOMINAL X-RAY WAS PERFORMED, WHICH SHOWED SEPARATION OF THE TUBE IN THE STOMACH. APPROXIMATELY 10 CM OF BROKEN TUBING WAS NOTED. PER ADDITIONAL INFORMATION RECEIVED ON 5 DEC 2017, THE SEPARATED DISTAL END WAS REMOVED VIA ENDOSCOPY AND NO FURTHER ISSUES WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7135354 ↗
  • InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE DATE OF THE EVENT IS UNKNOWN. THE TUBE WAS PLACED BLINDLY WITH SOME RESISTANCE BUT NOT MUCH DURING PLACEMENT. THE NEXT DAY, THERE WAS A LITTLE RESISTANCE WHEN THEY WERE FLUSHING THE TUBE WITH WATER, BUT IT DID NOT AFFECT THE FEEDING. THE THIRD DAY, THEY FOUND THE TUBE HAD PUNCTURED THE SMALL INTESTINAL WALL. THIS WAS FOUND UNDER THE ENDOSCOPE BEFORE AN OPERATION.

    Patient problems: Bowel Perforation

    MAUDE report 6243663 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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