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AVANOS 44094Recalls & 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 00350770440941), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

  • Fluid/Blood Leak1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 27, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

    IT WAS INITIALLY REPORTED THAT THE VALVE ON THE GASTRIC PORT OF THE GJ [GASTRO-JEJUNAL] TUBE WAS BROKEN RESULTING IN LEAKING FROM THE VALVE, REQUIRING THE TUBE TO BE REPLACED. TUBE WAS INSERTED ON (B)(6) 2020 AND PATIENT WAS AT HOME AT TIME OF BREAKAGE ON (B)(6) 2020. PATIENT ATTENDED MEDICAL IMAGING ON (B)(6) 2020 FOR TUBE CHANGE. ADDITIONAL INFORMATION RECEIVED 18-JAN-2021 INDICATED THE RETURNED SAMPLE EXHIBITED A TEAR IN THE INNER SEPTUM OF THE TUBING WHICH SEPARATES THE JEJUNAL AND GASTRIC LUMENS, ALLOWING FOR CROSS-LUMEN COMMUNICATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11237539 ↗

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.