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Halyard 44093Recalls & reported problems

Avanos Medical, Inc. · MICKEY,LPGJ,ISOKIT,-,16X2.0,1 · Class 2 · Implant

All models of Halyard (232)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10680651440935), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Leak/Splash1

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.

  • MalfunctionMar 7, 2018Break; Leak/Splash; Break; Leak/Splash

    IT WAS INITIALLY REPORTED ON (B)(6) 2017 THAT THE TUBE APPEARED TO BE DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS ORIGINALLY DEEMED A NOT REPORTABLE EVENT ACCORDING TO HALYARD HEALTH GUIDELINES. HOWEVER, THE SAMPLE WAS RECEIVED AND SAMPLE EVALUATION WAS COMPLETED ON (B)(6) 2018. THE SAMPLE EVALUATION CONFIRMED CROSS-LUMEN COMMUNICATION. WHEN FEEDING THROUGH THE JEJUNAL PORT, THE WATER EXITS THE GASTRIC SKIVES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE TUBE SEEMED TO HAVE MELTED. THE USER NOTICED DIAZEPAM IN THE FREE DRAINAGE BAG ONLY BECAUSE THE MEDICATION IS A PINK COLOR. NO PATIENT INJURY OCCURRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7320112 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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