Bard Button Replacement Gastrostomy DeviceRecalls & reported problems across all models
Bard Access Systems, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 9 models of Bard Button Replacement Gastrostomy Device by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2016 and Jul 6, 2024 — classified as 9 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (33 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bard Button Replacement Gastrostomy Device problems
Device problems
- Fluid/Blood Leak33
- Leak/Splash19
- Detachment Of Device Component7
- Break6
- Fitting Problem6
- Fracture6
- Migration or Expulsion of Device6
- Defective Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient20
- Pain5
- Swelling5
- Seizures3
- Skin Discoloration3
- Burn(s)2
Bard Button Replacement Gastrostomy Device models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard Button Replacement Gastrostomy Device 000282TUBE, GASTRO-ENTEROSTOMY25 reports
- Bard Button Replacement Gastrostomy Device 000283TUBE, GASTRO-ENTEROSTOMY16 reports
- Bard Button Replacement Gastrostomy Device 000286TUBE, GASTRO-ENTEROSTOMY13 reports
- Bard Button Replacement Gastrostomy Device 000287TUBE, GASTRO-ENTEROSTOMY13 reports
- Bard Button Replacement Gastrostomy Device 000285TUBE, GASTRO-ENTEROSTOMY7 reports
- Bard Button Replacement Gastrostomy Device 000284TUBE, GASTRO-ENTEROSTOMY6 reports
- Bard Button Replacement Gastrostomy Device 000262TUBE, GASTRO-ENTEROSTOMY1 report
- Bard Button Replacement Gastrostomy Device 000292TUBE, GASTRO-ENTEROSTOMY1 report
- Bard Button Replacement Gastrostomy Device 000296TUBE, GASTRO-ENTEROSTOMY1 report
Recent Bard Button Replacement Gastrostomy Device adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2024Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT SOMETIME POST A GASTROSTOMY FEEDING TUBE PLACEMENT, THE FEEDING TUBE ALLEGEDLY BROKE OFF INTO THE STOMACH WHILE REPLACING. IT WAS FURTHER REPORTED THAT THE SIZE TWENTY-EIGHT WAS NO LONGER MADE SO A SIZE TWENTY-SIX WAS ORDERED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19685274 ↗MalfunctionSep 19, 2022Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, BARD BUTTON ALLEGEDLY DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THAT BUTTON ALLEGEDLY PUNCTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15444642 ↗MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14683254 ↗MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14683252 ↗MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14683064 ↗MalfunctionApr 18, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING A GASTROSTOMY FEEDING TUBE PLACEMENT, THE CAP ALLEGEDLY NOT STAYING IN PLACE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY HAD LEAK. REPORTEDLY, IT CAUSES IRRITATION IN THE STOMACH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14133663 ↗MalfunctionJan 19, 2022Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, FOOD ALLEGEDLY WOULD NOT GO THROUGH THE FEEDING TUBE AND INTO THE BUTTON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13287653 ↗MalfunctionNov 29, 2021Fluid/Blood Leak; Defective Component; Difficult to Open or Close; Material Deformation; Fluid/Blood Leak; Defective Component; Difficult to Open or Close; Material Deformation
IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, ALLEGEDLY THE VALVE WAS DIFFICULT TO OPEN AND THE DEVICE LEAKED. IT WAS FURTHER REPORTED THAT WHITE FLAP OF THE DEVICE WAS TOO THIN AND CRUMPLED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882948 ↗MalfunctionNov 29, 2021Fluid/Blood Leak; Defective Component; Difficult to Open or Close; Material Deformation; Fluid/Blood Leak; Defective Component; Difficult to Open or Close; Material Deformation
IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, ALLEGEDLY THE VALVE WAS DIFFICULT TO OPEN AND THE DEVICE LEAKED. IT WAS FURTHER REPORTED THAT WHITE FLAP OF THE DEVICE WAS TOO THIN AND CRUMPLED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882947 ↗InjuryNov 26, 2021Fluid/Blood Leak; Reflux within Device; Defective Component; Difficult to Open or Close; Material Deformation; Fluid/Blood Leak; Reflux within Device; Defective Component; Difficult to Open or Close; Material Deformation
IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, THE DEVICE WAS ALLEGEDLY DIFFICULT TO OPEN AND THE DEVICE LEAKED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS TOO THIN AND THE PATIENT EXPERIENCED REFLUX AND TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED USING A DEVICE FROM ANOTHER COMPANY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12876553 ↗InjuryNov 1, 2021Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem
IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD A FITTING PROBLEM. PATIENT ALSO EXPERIENCED RASH AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Rash
MAUDE report 12726218 ↗MalfunctionNov 1, 2021Fracture; Fracture
IT WAS REPORTED THAT THE DURING THE PROCEDURE, FLAP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12726215 ↗MalfunctionOct 28, 2021Fracture; Fitting Problem; Fracture; Fitting Problem
IT WAS REPORTED THAT THE DURING A GASTROSTOMY FEEDING TUBE PLACEMENT, THE BUTTON ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A FITTING PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12712322 ↗MalfunctionAug 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT POST FEEDING DEVICE IMPLANT, THE DEVICE WAS ALLEGEDLY LEAKING PROFUSELY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12352008 ↗InjuryAug 12, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY HAD AN INFLAMMATION AND INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 12313030 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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