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AVANOS 47233Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastric-Jejunal Feeding Tube Kit · 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 00350770472331), received between Oct 21, 2020 and Oct 21, 2020 — 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

Patient problems

  • Vomiting1

Recent adverse event reports

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

  • MalfunctionOct 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THERE WAS A LEAK OF THE TUBE INTO THE PATIENT'S DUODENAL REGION FROM THE GASTRIC LUMEN. THE PATIENT HAD A RECENTLY REPLACEMENT OF THE GASTRO-JEJUNAL (GJ) TUBE AND HAD BEEN VOMITING. A CONTRAST STUDY WAS PERFORMED AS FOLLOWS: "THE PATIENT WAS PLACED IN THE RIGHT SIDE DOWN DECUBITUS POSITION AND THE EXTENSION TUBING CONNECTED TO THE GASTRIC PORT. CONTRAST WAS INJECTED, BUT DID NOT FILL THE STOMACH. CONTRAST PROMPTLY FILLED THE DUODENUM. APPROPRIATE CONNECTION OF THE TUBING TO THE GASTRIC PORT WAS CONFIRMED WITH THE TECHNOLOGIST. THE PATIENT WAS THEN TURNED SUPINE. CONTRAST WAS AGAIN SEEN IN THE DUODENUM, MORE SO PROXIMALLY. THE TUBE WAS FLUSHED WITH STERILE WATER. EXTENSION TUBING WAS ATTACHED TO THE J PORT OF THE EXISTING GASTROJEJUNOSTOMY TUBE. CONTRAST INJECTION DEMONSTRATES CONTRAST COMING FROM THE DISTAL TUBE FILLING THE DUODENO-JEJUNAL JUNCTION , AS EXPECTED."

    Patient problems: Vomiting

    MAUDE report 10713208 ↗

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.