Bard Button Replacement Gastrostomy Device 000287Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10801741087902), received between Jun 23, 2017 and Sep 19, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397366 ↗
• MalfunctionDec 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PORT PLACEMENT, THE DEVICE ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER BUTTON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940596 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000287 FEEDING TUBE ALLEGEDLY DETACHED. THE BUTTON WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813844 ↗
• MalfunctionJan 8, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BUTTON CONNECTIONS ON THE FEEDING TUBE WERE ALLEGEDLY LOOSE. IT WAS FURTHER REPORTED THAT MEDICATION ADMINISTERED THROUGH THE FEEDING TUBE, WOULD LEAK THROUGH THE PROBE. THE PATIENT WAS NOT ABLE TO REPORT ANY INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227580 ↗
• MalfunctionAug 3, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT DURING CURRENT USE OF A FEEDING DEVICE, THE PATIENT ALLEGEDLY EXPERIENCED "POPPING OFF" OF THE BUTTON COMPONENT. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747520 ↗
• MalfunctionFeb 9, 2018Leak/Splash; Material Deformation

  IT WAS REPORTED BY MS&S THAT THE NURSE CALLED AND STATED HER PATIENT'S BUTTON WAS REPLACED ON (B)(6) 2018. SHE STATED THAT SHE RECEIVED A CALL ON (B)(6) 2018 STATING THAT THE OPENING OF THE BUTTON WHERE THE EXTENSION TUBE CONNECTS HAS STRETCHED OUT CAUSING THE "FEEDING" TO LEAK. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260576 ↗
• MalfunctionSep 14, 2017Fracture

  IT WAS REPORTED THAT THE PATIENT HAD THE BUTTON FORM LESS THAN 60 DAYS. THE FISSURE AT THE BASE OF THE CAP RESULTED IN EXTRAVASATION OF DIET OR ANY OTHER SOLUTION WHEN INJECTED. WHEN THE DEVICE WAS REMOVED THE WITHDRAWAL CAP OF THE BUTTON FRACTURED COMPLETELY AND DID NOT RESIST THE NECESSARY PRESSURE THAT THE PROCEDURE REQUIRED RESULTING IN LIGHT BLEEDING IN THE OSTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866682 ↗
• MalfunctionJul 27, 2017Material Integrity Problem

  IT WAS REPORTED THAT PATIENT'S MOTHER CALLED THE HOME HEALTHCARE FACILITY ALLEGEDLY REPORTING A "BALL" ON THE TAB OF THE BUTTON APPARENTLY "RIPPED." NO HARM CAUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6748970 ↗
• MalfunctionJul 7, 2017Device Inoperable

  IT WAS REPORTED THAT PATIENT'S MOTHER CALLED THE REPORTING FACILITY STATING THE TAB ON THE BUTTON HAD RIPPED. NO HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693842 ↗
• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE BARD BUTTON WAS STRESSED AND BROKE OFF INTO THE PATIENT'S STOMACH. IT WAS STATED THAT THE HOSPITAL ADVISED CONTACT THAT IT WOULD COME OUT IN HIS BOWEL MOVEMENTS BUT THAT HAS YET TO BE SEEN. THE PATIENT IS TAKING LIQUID CALLED ISO WHICH SEEMS TO BE WORKING WELL FOR PATIENT. THIS REPORT ADDRESSES EVENT THREE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6664928 ↗
• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE BARD BUTTON WAS STRESSED AND BROKE OFF INTO THE PATIENT'S STOMACH. THE DEVICE WAS REMOVED AND REPLACED. THIS REPORT ADDRESSES EVENT TWO.

  Patient problems: Foreign Body In Patient

  MAUDE report 6664896 ↗
• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE BARD BUTTON WAS STRESSED AND BROKE OFF INTO THE PATIENT'S STOMACH. THE DEVICE WAS REMOVED AND REPLACED. THIS REPORT ADDRESSES EVENT ONE.

  Patient problems: No Code Available

  MAUDE report 6664890 ↗