Bard Button Replacement Gastrostomy Device 000283Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801741087865), received between Aug 30, 2016 and Apr 18, 2022 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S BUTTON GASTROSTOMY TUBE IS LEAKING THROUGH THE VALVE/CENTER OF THE BUTTON. THE BUTTON WAS REMOVED AND A NEW BUTTON WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679432 ↗
• MalfunctionJul 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S BUTTON GASTROSTOMY TUBE IS LEAKING THROUGH THE VALVE/CENTER OF THE BUTTON. THE BUTTON WAS REMOVED AND A NEW BUTTON WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679365 ↗
• MalfunctionJul 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S BUTTON IS LEAKING THROUGH THE VALVE/CENTER OF THE BUTTON. THE BUTTON IS STILL IN USE, THE EXTENSION TUBE IS LEFT IN TO KEEP IT FROM LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679202 ↗
• MalfunctionJul 11, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S BUTTON GASTROSTOMY TUBE IS LEAKING THROUGH THE VALVE/CENTER OF THE BUTTON. THE BUTTON WAS REMOVED AND A NEW BUTTON WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679199 ↗
• MalfunctionMay 9, 2018Failure to Infuse; Failure to Infuse

  IT WAS REPORTED DIFFICULTY DRAINING THE DEVICE. DEVICE REMAINS IN PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7499770 ↗
• MalfunctionNov 29, 2017Migration or Expulsion of Device

  PER THE REPORTING FACILITY, THE CHILD'S PARENTS WERE CARING FOR THE DEVICE ON DISCHARGE HOME AFTER RECEIVING EDUCATION FROM THE FACILITY'S TEAM. THE DEVICE WAS INTACT BUT HAD MIGRATED OUT OF THE PATIENT'S STOMACH. THIS WAS DISCOVERED DUE TO THE CHILD COMPLAINING OF PAIN, THE PRESENCE OF SWELLING AND REDNESS AT THE INSERTION SITE, AND THE DEVICE WAS NO LONGER SITTING FLUSH AGAINST THE SKIN; THE SHAFT OF THE DEVICE WAS VISIBLE AND USUALLY ON AN ANGLE THERE IS AN OBVIOUS LUMP AT THE SITE. THERE WAS NO COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Pain; Swelling

  MAUDE report 7068531 ↗
• MalfunctionNov 29, 2017Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2017 THAT THE DOME MIGRATED. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED. THERE WAS NO REPORTED PATIENT INJURY. ON (B)(6) 2017 - PER THE REPORTING FACILITY, THE CHILD'S PARENTS WERE CARING FOR THE DEVICE ON DISCHARGE HOME AFTER RECEIVING EDUCATION FROM THE FACILITY'S TEAM. THE DEVICE WAS INTACT BUT HAD MIGRATED OUT OF THE PATIENT'S STOMACH. THIS WAS DISCOVERED DUE TO THE CHILD COMPLAINING OF PAIN, THE PRESENCE OF SWELLING AND REDNESS AT THE INSERTION SITE, AND THE DEVICE WAS NO LONGER SITTING FLUSH AGAINST THE SKIN; THE SHAFT OF THE DEVICE WAS VISIBLE AND USUALLY ON AN ANGLE THERE IS AN OBVIOUS LUMP AT THE SITE. THERE WAS NO COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Skin Discoloration; Swelling

  MAUDE report 7068200 ↗
• MalfunctionAug 31, 2017Detachment Of Device Component; Fluid/Blood Leak; Difficult to Open or Close

  IT WAS REPORTED BY THE PATIENT¿S MOTHER THAT HER CHILD HAS A BARD BUTTON THAT IS LEAKING. THE DEVICE WAS PLACED (B)(6) 2017, AND HAS BEEN LEAKING SINCE THE DAY AFTER PLACEMENT. THE TAB THAT CLOSED THE DEVICE CAME OFF AND HAS NEVER REALLY HAD A GOOD SEAL AROUND THE FEEDING TUBE. IT APPEARS THE VALVE ISN¿T CLOSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835996 ↗
• MalfunctionJul 25, 2017Detachment Of Device Component; Stretched

  IT WAS REPORTED BY THE FACILITY, VIA MS&S, THAT THE DIETICIAN HAS A PATIENT WITH A BUTTON WHOSE MOM WANTS A FEEDING EXTENSION. THE DIETICIAN FOUND AN EXTENSION, BUT THE MOM WANTS ONE SHORTER, WHICH SHE CAN'T FIND ANYTHING LIKE THIS ON THE WEBSITE. THE MOM STATES "IT POPS OUT" AND NEEDS TO KNOW IF THERE IS ANYTHING TO SECURE THE EXTENSION INTO THE BUTTON. MS&S PROVIDED HER WITH THE PRODUCT INFORMATION AND TOLD HER THAT IF THE EXTENSION TUBE POPS OUT, IT IS POSSIBLE THE DEVICE HAS BEEN STRETCHED OUT OVER TIME OR IT IS POSSIBLE THE AIR/GAS COULD PUSH IT OUT. MS&S TOLD HER THAT IF IT IS AIR OR GAS THEN USING A DECOMPRESSION TUBE MAY HELP. MS&S INQUIRED WHEN THE TUBE POPS OUT, IS IT AT RANDOM TIMES OR WHEN THE PATIENT IS ACTIVE OR SLEEPING? MS&S ALSO INQUIRED AS TO HOW LONG THE BUTTON DEVICE HAS BEEN PLACED. THE MOTHER STATED SHE DID NOT KNOW HOW LONG THE BUTTON DEVICE HAS BEEN IN, BUT SHE THINKS IT IS LESS THAN ONE YEAR. THE MOTHER ALSO STATED THAT THE DOCTOR CHANGED THE PATIENT'S PREVIOUS TUBE AND REPLACED IT WITH A BUTTON BECAUSE "THE MOM WAS NOT HAPPY WITH THE PREVIOUS TUBE". MS&S PROVIDED THE DIETICIAN THE PRODUCT NUMBERS AND DESCRIPTIONS AND SUGGESTED THAT THE PATIENT'S MOM COULD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742420 ↗
• MalfunctionJul 14, 2017Leak/Splash; Defective Component

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE FEEDING BUTTON CONTINUES TO LEAK WHEN THE CAP IS CLOSED. THE MOTHER STATED THAT WHEN THE CAP IS OPEN IT WILL DRAIN LIKE AN "OPEN" FACET. WHEN ITS "CLOSED" IT DRIPS LIKE A LEAKING FACET. THIS HAS CAUSED STOMACH ACID TO LEAK ON HER SON'S SKIN AND CAUSED HIM TO BE AGITATED. SHE WOULD LIKE TO KNOW IF THERE WAS A CHANGE IN THE DESIGN OF THE BUTTON. IN THE PAST HER SON COULD GO MONTHS BEFORE THE DEVICE NEEDED TO BE REPLACED, NOW SHE HAS REPLACED TWO IN THE LAST FOUR MONTHS. THE MOTHER NOTED THAT IN THE PAST THERE HAS NOT BEEN A COMPANY LOGO ON THE DEVICE. SHE HAS NOTICED WITH THE TWO RECENT REPLACEMENT DEVICES THE COMPANY LOGO IS IMPRINTED ON THE BUTTON. SHE WOULD LIKE TO KNOW IF A CHANGE WAS MADE TO THE DEVICE THAT IS CAUSING THE BUTTON TO LEAK WHEN THE LOGO WAS ADDED TO THE DEVICE. SHE HAS REQUESTED A IFU BE SENT TO HER FOR ASSISTANCE IN REPLACING THE PATIENT'S DEVICE. THIS FILE ADDRESSES THE INITIAL BUTTON REPLACEMENT.

  Patient problems: Emotional Changes

  MAUDE report 6713565 ↗
• MalfunctionJul 14, 2017Fluid/Blood Leak; Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE FEEDING BUTTON CONTINUES TO LEAK WHEN THE CAP IS CLOSED. THE MOTHER STATED THAT WHEN THE CAP IS OPEN IT WILL DRAIN LIKE AN "OPEN" FAUCET. WHEN ITS "CLOSED" IT DRIPS LIKE A LEAKING FAUCET. THIS HAS CAUSED STOMACH ACID TO LEAK ON HER SON'S SKIN AND CAUSED HIM TO BE AGITATED. SHE WOULD LIKE TO KNOW IF THERE WAS A CHANGE IN THE DESIGN OF THE BUTTON. IN THE PAST HER SON COULD GO MONTHS BEFORE THE DEVICE NEEDED TO BE REPLACED, NOW SHE HAS REPLACED TWO IN THE LAST FOUR MONTHS. THE MOTHER NOTED THAT IN THE PAST THERE HAS NOT BEEN A COMPANY LOGO ON THE DEVICE. SHE HAS NOTICED WITH THE TWO RECENT REPLACEMENT DEVICES THE COMPANY LOGO IS IMPRINTED ON THE BUTTON. SHE WOULD LIKE TO KNOW IF A CHANGE WAS MADE TO THE DEVICE THAT IS CAUSING THE BUTTON TO LEAK WHEN THE LOGO WAS ADDED TO THE DEVICE. SHE HAS REQUESTED A IFU BE SENT TO HER FOR ASSISTANCE IN REPLACING THE PATIENT'S DEVICE. THIS FILE ADDRESSES THE SECOND BUTTON REPLACEMENT.

  Patient problems: Skin Irritation

  MAUDE report 6713556 ↗
• MalfunctionAug 30, 2016Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING REMOVAL OF A BARD GASTRIC BUTTON WITHOUT BALLOON, THE HEALTH PROFESSIONAL PRESSED TO STRETCH THE DEVICE WITH A KIND OF WIRE ¿PUNCH¿ TO REMOVE THE BUTTON, BUT IT WAS CUT, BEING PRACTICALLY ENTIRELY INSIDE THE PATIENT'S ABDOMEN. THE PATIENT SUBMITTED TO STOMACH PAIN AND DIFFICULTY MAKING STOOLS. THE DOCTOR SAID THAT HE WOULD ELIMINATE IT IN A NATURAL WAY BETWEEN THREE DAYS AND A MONTH. AFTER 18 DAYS, THE BUTTON WAS NATURALLY EXCRETED. NO PATIENT INJURY REPORTED.

  Patient problems: Abdominal Pain; Constipation

  MAUDE report 5916228 ↗