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AVANOS 46204Recalls & reported problems

Avanos Medical, Inc. · CORFLO* Standard PEG Kit - Pull Method · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770462042), received between Dec 15, 2020 and May 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Expulsion1
  • Fracture1

Patient problems

  • Foreign Body In Patient1
  • Granuloma1
  • No Clinical Signs, Symptoms or Conditions1
  • Unspecified Infection1

Recent adverse event reports

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

  • MalfunctionMay 6, 2022Fracture; Expulsion; Fracture; Expulsion

    IT WAS ORIGINALLY REPORTED THAT THE CORFLO PEG TUBE HAD DISLODGED FROM THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 13 APR 2022, IMAGES WERE RECEIVED THAT SHOWED THAT THE PEG BUMPER HAD BROKEN OFF. PER ADDITIONAL INFORMATION RECEIVED 14 APR 2022, THERE WAS NO MEDICAL INTERVENTION REQUIRED, HOWEVER THE REPORTER DID NOT KNOW IF THE BUMPER HAD PASSED THROUGH THE PATIENT NATURALLY. THE PATIENT'S CURRENT CONDITION WAS DESCRIBED AS "WELL." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 14311269 ↗
  • InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S STOMA SITE WAS PAINFUL AND SENSITIVE WITH GRANULATION TISSUE PRESENT. PATIENT WAS PRESCRIBED MAXITROL. DEVICE HAS BEEN IN USE FOR 6 WEEKS. PATIENT'S CURRENT CONDITION WAS LISTED AS "WELL."

    Patient problems: Granuloma; Unspecified Infection

    MAUDE report 11010783 ↗

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.