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CORFLO PEG Kit 50-6020E2Recalls & reported problems

Corpak Medsystems, Inc. · PEG Kit with ENFit Connectors Pull Technique · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815149021802), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE TUBE BROKE OR WAS CUT DURING THE PROCEDURE TO PLACE THE DEVICE. THE CUT WAS ON THE LEVEL OF THE WIRE THAT THE OPERATOR USES TO PULL THE PROBE OUT FROM THE INSIDE OF THE STOMACH. THE CUT PIECE WAS RETRIEVED USING KOCHER FORCEPS, BUT IT WAS DIFFICULT TO ADAPT THE EXTERNAL FIXATIONS TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9215821 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.