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Halyard 10226Recalls & reported problems

Avanos Medical, Inc. · HALYARD* Laparoscopic Introducer Kit for Gastrostomy Feeding Tube · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651102260), received between Jan 3, 2017 and Aug 31, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2017Break; Break

    CALL FROM PHYSICIAN REPORTING "2 SUTURES BROKE FROM THE PLACEMENT KIT, IT APPEARS THE BREAK IS PROXIMAL TO THE T-BAR. I PLACED THE TUBE AND T-FASTENERS YESTERDAY ON A (B)(6) FEMALE AND THIS MORNING ON ROUNDS TWO OF THE 3 SUTURES WERE BROKEN. THE 3 CM OF SUTURE WAS STILL ATTACHED TO THE CLIP, WHICH IS APPROX. LENGTH OF THE STOMA, I FEEL AS THOUGH THE SUTURE IS NOT STRONG ENOUGH TO SUPPORT THE NORMAL SKIN SWELLING THAT COMES FROM NEW PLACEMENT OF THE TUBE. THERE WAS NO PATIENT INJURY AND THE TUBE APPEARED TO BE INTACT AND IN THE CORRECT POSITION."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6837199 ↗
  • MalfunctionJan 3, 2017Break; Break

    IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE TO PLACE A MIC-KEY FEEDING TUBE. ON (B)(6) 2016 THE PATIENT PICKED AT THE SCAB WOUND AND ALLEGED THAT A SMALL PIECE OF METAL CAME FROM THE SCAB AREA. ADDITIONAL INFORMATION WAS RECEIVED ON 20-DEC-2016 FROM THE HALYARD REPRESENTATIVE WHO WAS PRESENT DURING THE PATIENT'S PROCEDURE ON (B)(6) 2016. THE HALYARD REPRESENTATIVE STATES THE PROCEDURE WAS DONE LAPAROSCOPY AND THE T-FASTENERS WERE PLACED CORRECTLY, AND THE T-FASTENERS WERE NOT TIGHT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE CORRECT TECHNIQUE. THE WERE NO ISSUES OR CONCERNS WITH THE PROCEDURE THAT LASTED APPROXIMATELY TEN MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6218374 ↗

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.