Skip to content

AVANOS 44181Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Continuous Feed Extension Set with ENFit® Connectors, SECUR-LOK* · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770441818), received between Mar 14, 2022 and Nov 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Material Separation1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 8, 2024Break; Break

    IT WAS REPORTED, "END USER REPORTS THAT THE CAP ON THE END OF THE EXTENSION TUBE DETACHED FROM THE PLASTIC TETHER. HAPPENED WHILE A FEED WAS RUNNING. POTENTIAL CHOKING HAZARD FOR CHILD."

    Patient problems: Insufficient Information

    MAUDE report 20643559 ↗
  • MalfunctionMar 14, 2022Material Separation; Material Separation

    IT WAS REPORTED "THE CAP WAS EASILY DISPLACED FROM THE TETHER. NURSE REPORTED THE MALE CHILD PULLED ON CAP AN IT CAME OFF OF TETHER." THERE WAS NO REPORTED INJURY AND THERE WAS NO REPORT THE PATIENT PUT THE COMPONENT IN HIS MOUTH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13764866 ↗

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page