Bard Button Replacement Gastrostomy Device 000285Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801741087889), received between Apr 18, 2019 and Apr 27, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730362 ↗
• MalfunctionJan 5, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY BROKE EXTERNALLY AND WAS LEAKING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115608 ↗
• MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SEVEN DAYS POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD LEAK. IT WAS FURTHER REPORTED THAT THE FEEDING DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10746542 ↗
• InjuryAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE BUTTON VALVE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED BURNS IN THE GASTRO, MAJOR SEIZURES, WEIGHT LOSS. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Seizures

  MAUDE report 10384047 ↗
• MalfunctionJul 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000285 FEEDING DEVICE ALLEGEDLY LEAKED . THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WHO EXPERIENCED SEIZURES. THE AGE AND WEIGHT OF THE FEMALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; Seizures

  MAUDE report 10284004 ↗
• InjuryJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE BUTTON VALVE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED BURNS IN THE GASTRO, MAJOR SEIZURES, WEIGHT LOSS. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Seizures

  MAUDE report 10210699 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 000285 BUTTON GASTROSTOMY TUBE KITS ALLEGEDLY A LEAK WAS IDENTIFIED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529671 ↗