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AVANOS 44093Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastric-Jejunal Feeding Tube Kit Extension Sets · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770440934), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. May 31, 2024Open, Classified

    The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

    Z-2422-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionJul 6, 2022Break; Break

    IT WAS REPORTED THAT THE TUBE BROKE, THE DISTAL PORTION PASSED WITHOUT INCIDENT. THERE WAS NO REPORTED INJURY.

    Patient problems: Foreign Body In Patient

    MAUDE report 14929781 ↗

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.