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AVANOS 42721Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets with ENFit® Connector · 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 00350770427218), received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

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: 0 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: 1 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

  • Device Dislodged or Dislocated1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMay 29, 2026Device Dislodged or Dislocated

    THE CUSTOMER REPORTED THAT A FEEDING TUBE WAS FOUND DISLODGED WHILE THE PATIENT WAS RESIDING IN A CARE HOME. ATTEMPTS TO REINSERT A REPLACEMENT TUBE WERE UNSUCCESSFUL, AND THE PATIENT WAS TRANSFERRED FOR FURTHER MEDICAL MANAGEMENT. ENDOSCOPIC INTERVENTION WAS SUBSEQUENTLY PERFORMED AND A REPLACEMENT PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS INSERTED. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING TREATMENT. ADDITIONAL FOLLOW-UP INFORMATION REPORTED "I PRESUME A NEW STOMA TRACT WAS MADE, AS THE PATIENT PREVIOUSLY HAD A 12FR, AND NOW HAS A 16FR, HOWEVER ITS IN ROUGHLY THE SAME LOCATION IN THE ABDOMEN."

    Patient problems: Insufficient Information

    MAUDE report 25332503 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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