Halyard 98703Recalls & reported problems
Avanos Medical, Inc. · HALYARD* Enteral Access Dilation System · Class 2 · Implant
- 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 10680651987034), received between Sep 26, 2019 and Jan 14, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Bowel Perforation1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Break; Break
ADDITIONAL INFORMATION (B)(6) 2025 STATED THE DISTAL TIP OF DILATOR WAS SUPPOSEDLY RETAINED IN THE ESOPHAGEAL WALL OR ABDOMINAL CAVITY. "THE OPERATION WAS PERFORMED ENDOSCOPICALLY, AND GUIDEWIRE WAS USED.".
Patient problems: Foreign Body In Patient
MAUDE report 21148586 ↗MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED 09-OCT-2019 STATED IT WAS THE SHEATH THAT SURROUNDS THE INTRODUCER/DILATOR THAT SEPARATED FROM THE DEVICE. IT WAS NOT NOTICED IF THE PIECE CAME OFF THE DEVICE WHEN THE USER WITHDREW THE DILATOR. THE PIECE THAT CAME OFF THE INTRODUCER/DILATOR PERFORATED THE BOWEL. THE PIECE THAT WAS IN THE PATIENT¿S ABDOMEN AS A "FOREIGN OBJECT" WAS THE DEVICE THAT CAME OFF THE INTRODUCER/DILATOR.
Patient problems: Bowel Perforation
MAUDE report 9126463 ↗
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.