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Halyard 98702Recalls & reported problems

Avanos Medical, Inc. · HALYARD* Enteral Access Dilation System · Class 2 · Implant

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 10680651987027), received between Nov 22, 2022 and Nov 22, 2022 — 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. How this data works · Data updated Oct 13, 2026.

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.

  • MalfunctionNov 22, 2022Break; Break

    IT WAS REPORTED THE "TIP OF THE DILATOR DETACHED AND DROPPED INTO STOMACH. THE DETACHED PART WAS COLLECTED DURING PROCEDURE, NO PATIENT INJURY. GASTROSTOMY SURGERY WAS PERFORMED AT ANTRUM OF STOMACH INAPPROPRIATELY, SO STYLET WAS TOO CLOSE TO LESSER CURVATURE OF STOMACH. IT WAS SUPPOSED THAT IT CAUSED THE DILATOR'S DAMAGE. THE GASTROSTOMY TUBE REPLACEMENT WAS SUCCEEDED." THERE WAS NO REPORTED INJURY.

    Patient problems: Foreign Body In Patient

    MAUDE report 15848894 ↗

Other TUBE, GASTRO-ENTEROSTOMY devices

All TUBE, GASTRO-ENTEROSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.