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AVANOS 42734Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770427348), received between Apr 20, 2022 and Apr 20, 2022 — classified as 1 malfunction.

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

  • Fracture1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionApr 20, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE FEEDING TUBE FELL OUT OF THE PATIENT BUT THAT THE BALLOON BROKE AND THE PIECES LEFT INSIDE. NO FURTHER CLARIFICATION WAS ABLE TO BE PROVIDED AT THAT TIME. PER INFORMATION RECEIVED 29 MAR 2022 BASED ON THE EVALUATION THE SAMPLE, IT WAS DETERMINED THAT THE TUBE HAD BROKEN OFF COMPLETELY. PER ADDITIONAL INFORMATION RECEIVED ON 8 APR 2022 FROM THE ORIGINAL REPORTER, THERE HAS BEEN NO REPORT OF THE BROKEN OFF PIECE BEING PASSED NATURALLY, HOWEVER NO MEDICAL INTERVENTION HAS BEEN REQUIRED. THE DOCTOR DETERMINED THAT IT SHOULD PASS NATURALLY EVENTUALLY.

    Patient problems: Foreign Body In Patient

    MAUDE report 14163598 ↗

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.