CORFLO PEG Kit 50-6012E1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815149021741), received between Jul 2, 2018 and Oct 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT'S CAREGIVER FOUND IT DIFFICULT TO ADVANCE THE PEG TUBE THE LAST TWO TIMES OPENING THE FIXATOR PLATE. AFTER A COUPLE OF HOURS, IT WAS NOTICED THE STOMA SITE WAS RED, AND SWOLLEN. PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT, AND COMMENCED ON ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED 14-SEP-2020 INDICATED THAT THE PATIENT'S CURRENT CONDITION, AND WHETHER ANY OTHER MEDICAL INTERVENTIONS WERE REQUIRED ARE UNKNOWN.

  Patient problems: Skin Inflammation; Swelling

  MAUDE report 10631261 ↗
• MalfunctionJul 2, 2018Migration or Expulsion of Device; Human Factors Issue; Migration or Expulsion of Device; Human Factors Issue

  IT WAS REPORTED THAT A DOCTOR CUT AND PUSHED THE PATIENT'S PEG TUBE INSIDE THE STOMACH, IN ORDER TO PLACE A MIC KEY DEVICE. A WEEK LATER, THE PATIENT BECAME UNWELL AND WAS APPARENTLY CHOKING. WHEN THE PARENT INTERVENED, THE PATIENT VOMITED UP THE CUT PEG. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Choking; Vomiting

  MAUDE report 7656980 ↗