CORFLO PEG Kit 30-6516Recalls & reported problems
Corpak Medsystems, Inc. · PEG Kit , basic components, Pull Technique · Class 2 · Implant
Data updated Oct 16, 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 10815149024223), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER 20 WEEKS, THE PEG SNAPPED DURING TRACTION REMOVAL. THE DEVICE'S INTERNAL BUMPER WAS LEFT INSIDE THE PATIENT'S STOMACH. IT WAS ADVANCED AND ROTATED PRIOR TO REMOVAL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9763196 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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