Bard Button Replacement Gastrostomy Device 000296Recalls & reported problems
Bard Access Systems, Inc. · 24 Fr x 4.4cm Button Kit · Class 2 · Implant
Data updated Oct 13, 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 10801741087933), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
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.
MalfunctionNov 17, 2017Migration or Expulsion of Device
IT WAS REPORTED ON (B)(4) 2017 THAT THE DOME MIGRATED OUT OF THE STOMACH WITHIN THE FIRST FEW MONTHS AFTER INSERTION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7042863 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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