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CORFLO PEG Kit 50-6516Recalls & reported problems

Corpak Medsystems, Inc. · PEG Kit with ENFit connectors basic components Pull Technique · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 10815149021680), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionAug 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THERE WAS A DISPLACEMENT OF THE PEG TUBE WITH THE INTERNAL BUMPER MISSING. A NEW BALLOON GASTROSTOMY TUBE WAS INSERTED. PATIENT ADVISED THAT BUMPER SHOULD PASS THROUGH BOWEL MOVEMENTS, BUT TO REPORT TO A&E SHOULD HE EXPERIENCE SYMPTOMS OF OBSTRUCTION.

    Patient problems: Foreign Body In Patient

    MAUDE report 8945806 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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