Halyard 10240Recalls & reported problems
Avanos Medical, Inc. · HALYARD* Laparoscopic Introducer Kit for Gastrostomy Feeding Tube · Class 2
- 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 10680651102406), received between Sep 10, 2018 and Sep 10, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence 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 10, 2018Break; Break
IT WAS REPORTED THE T-FASTENERS BROKE DURING PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7860807 ↗
Other TUBE, GASTRO-ENTEROSTOMY devices
- AVANOS 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY93 reports
- AVANOS 98432Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY72 reports
- Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death61 reports
- Halyard 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death40 reports
- Halyard 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY35 reports
- AVANOS 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY34 reports
- AVANOS 98430Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death29 reports
- Halyard 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.