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AVANOS 44088Recalls & 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 00350770440880), received between Sep 2, 2020 and Sep 2, 2020 — 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
  • Complete Blockage1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 2, 2020Break; Complete Blockage; Break; Complete Blockage

    IT WAS REPORTED THAT WHEN THE PATIENT WAS IN IR [INTERVENTIONAL RADIOLOGY] FOR A TUBE CHANGE, THE TUBE WAS REMOVED BUT THE J-PORTION [JEJUNAL PORTION] OF THE TUBE WAS BROKEN OFF AND REMAINED IN PATIENT¿S JEJUNUM. THE PATIENT WAS ABLE TO SUCCESSFULLY PASS THE J-PORTION IN HER STOOL NATURALLY. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 14-AUG-2020 INDICATED THE PATIENT'S CURRENT STATUS WAS "STABLE OUTPATIENT." THERE WERE NO ADVERSE EFFECTS RELATED TO THE INCIDENT. THE PATIENT REQUIRED OVERNIGHT ADMISSION AND CLOSE MEDICAL OBSERVATION. THE PATIENT WAS DISCHARGED THE NEXT AFTERNOON AFTER PASSING THE J-TUBE [JEJUNAL TUBE] EXTENSION IN BOWEL MOVEMENT NATURALLY. THE FEEDING TUBE WAS IN PLACE FOR 33 DAYS WITH THE LAST TUBE EXCHANGE TAKING PLACE ON 05-JUL-2020. BOTH LIQUIDS AND CRUSHED MEDICATIONS WERE INFUSED VIA THE TUBE AND THERE IS A HISTORY OF TUBE CLOGGING. CLOGGING WAS RESOLVED BY "SYRINGE PUSH WITH FORCE." THE PARENT "WAS ADVISED TO USE SOME FORCE TO PUSH CRUSHED MEDICATION INTO J-PORT [JENUAL PORT]."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10485766 ↗

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.