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AVANOS 42736Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets with ENFit® Connector · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770427362), received between Sep 10, 2020 and Sep 10, 2020 — classified as 1 injury.

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

Patient problems

  • Bacterial Infection1
  • Fungal Infection1
  • Pain1

Recent adverse event reports

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

  • InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED BACTERIAL AND FUNGAL INFECTIONS AT THE STOMA SITE. THE SITE IS ALSO SORE. REPORTER (IDENTIFIED AS "CARER") HAS DETERMINED THAT PATIENT'S DEVICE SHOULD BE SWAPPED FOR A NEW ONE. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Bacterial Infection; Fungal Infection; Pain

    MAUDE report 10514042 ↗

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.