Injection Gold Probe M00560150Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 08714729056492), received between May 16, 2017 and Sep 22, 2026 — classified as 1 death, 11 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (42 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that an Injection Gold Probe was intended to be used during a procedure on an unknown date.The device exhibited a condition where the end of the device broke off. The procedure outcome is not known.There are no known patient complications reported for this event.Boston Scientific Corporation has been unable to obtain additional information despite Good Faith Efforts.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850408 ↗
• MalfunctionSep 18, 2026Break

  Gold probe broke off inside scope.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818356 ↗
• MalfunctionJun 1, 2026Component Missing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, WHEN THE NEEDLE WAS INTENDED TO BE EXTENDED, IT WAS NOTED THAT THE NEEDLE WAS MISSING FROM THE DEVICE. ANOTHER DEVICE FROM THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354706 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE CARDIA OF THE STOMACH DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE TIP OF THE INJECTION GOLD PROBE BROKE OFF. THE DETACHED TIP REPORTEDLY DID NOT ENTER THE PATIENT AND WAS REMOVED FROM THE ENDOSCOPE. THE PHYSICIAN ABORTED THE PROCEDURE, AND IT WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251023 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INJECTION GOLD PROBE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GOLD PROBE WAS INSERTED THROUGH THE SCOPE. MIDWAY THROUGH USING THE GOLD PROBE, THE DISTAL GOLD TIP DETACHED FROM THE END OF THE CATHETER AND FELL INTO THE PATIENT'S STOMACH. THE TIP WAS RETRIEVED BY SUCTIONING IT THROUGH THE SCOPE. THEY USED ANOTHER GOLD PROBE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646762 ↗
• InjuryNov 20, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ENTIRE DISTAL GOLD TIP DETACHED FROM THE END OF THE CATHETER AND FELL INTO THE PATIENT. THE DISTAL GOLD TIP WAS RETRIEVED, AND ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607548 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE GOLD PROBE PORTION ITSELF, CAME DISLODGE FROM THE CATHETER AND WAS LEFT STICKING OUT OF THE BIOPSY CAP. NO HARM WAS CAUSED TO THE PATIENT, BUT IT DID CAUSE A DELAY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328843 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE STOMACH DURING A HEMOSTASIS - FOR BLEEDING ULCER PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE FELL OFF OR CAME OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTION GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323383 ↗
• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE DEVICE AND FELL OFF INTO THE PATIENT. THE DETACHED NEEDLE WAS REMOVED FROM THE PATIENT USING A NET AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312486 ↗
• MalfunctionOct 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED ON A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PROBE WAS FOUND TO BE NOT HEATING UPON CONTACT WITH THE PATIENT'S MUCOSA. WHEN THE EQUIPMENT WAS WITHDRAWN FROM THE BIOPSY CHANNEL, THE TIP OF THE PROBE WAS OBSERVED TO BE MISSING. A PHOTO OF THE PROBE WAS PROVIDED, SHOWING THAT THE DISTAL GOLD TIP WAS NO LONGER ATTACHED TO THE END OF THE CATHETER. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248728 ↗
• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE DUODENUM DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE BROKE DOWN AND THE TIP OF THE DEVICE REMAINED INSIDE THE DUODENUM OF THE PATIENT. THE TIP OF THE DEVICE WAS RETRIEVED USING A BASKET AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22958028 ↗
• MalfunctionAug 12, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE DUODENUM DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE GOLD PROBE TIP DETACHED FROM CATHETER. IT WAS UNCLEAR IF DETACHED IN CHANNEL OR OUT OF END OF SCOPE. THE PROCEDURE WAS COMPLETED USING A RESOLUTION CLIP. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786291 ↗
• MalfunctionAug 8, 2025Structural Problem

  ATTEMPTED TO USE GOLD PROBE INJECTOR NEEDLE IT WAS NOT RECOGNISED BY THE ERBE UNPLUGGED REMOVED AND SWITCHED MACHINE OFF TURNED MACHINE ON RE PLUGGED IN STILL DID NOT RECOGNISE EQUIPMENT REMOVED FROM SCOPE AND NON-INJECTOR GOLD PROBE PLUGGED IN AND USED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748057 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE ENTIRE DISTAL GOLD TIP DETACHED FROM THE END OF THE CATHETER AND FELL INTO THE PATIENT. ANOTHER INJECTION GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. BLEEDING WAS REPORTED BUT PER THE PHYSICIAN'S OPINION, DEVICE OR PROCEDURE DID NOT CONTRIBUTE TO THE COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677025 ↗
• MalfunctionJul 31, 2025Break; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Break; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS FAULTY AFTER CONNECTED TO ENERGY. WHEN WANTING TO BURN, NEEDLE STARTED TO BEND AND BREAK. ANOTHER INJECTION GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE TIP WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674276 ↗
• MalfunctionJul 24, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE INJECTION GOLD PROBE COULD NOT BE ENERGIZED. HEMOSTASIS WAS ATTEMPTED USING CLIPS; HOWEVER, IT WAS UNSUCCESSFUL BECAUSE THE SOURCE OF BLEEDING COULD NOT BE VISUALIZED. THE PROCEDURE WAS THEREFORE CONVERTED TO SURGERY; SUTURES WERE APPLIED TO CONTROL THE BLEEDING. THE PATIENT SUBSEQUENTLY MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585783 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL GOLD TIP DETACHED FROM THE CATHETER INTO THE PATIENT. THE TIP WAS NOT REMOVED AND WAS LEFT IN THE PATIENT TO PASS NATURALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER INJECTION GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288281 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP BECOME SEPARATED FROM THE CATHETER BUT REMAIN ATTACHED TO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTION GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143803 ↗
• MalfunctionApr 17, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO USE A GOLD PROBE TO CAUTERIZE A BLEEDER, BUT IT DID NOT WORK UPON PRESSING THE FOOT PEDAL TO GIVE THE GOLD PROBE ENERGY. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE TIP WAS CRACKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859571 ↗
• MalfunctionApr 3, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE DUODENUM DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE OPENED AND SET UP YET WAS NOT DELIVERING POWER. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS, THAT TIP WAS CRACKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762359 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE NEEDLE WAS ADVANCED TO INJECT, THE DISTAL GOLD TIP SLID FORWARD FROM THE CATHETER. THE TIP WAS STILL ATTACHED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER GOLD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686894 ↗
• MalfunctionMar 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON FEBRUARY 11, 2025. DURING THE PROCEDURE, THE INJECTION GOLD PROBE WAS USED TO TREAT BLEEDING. THE CATHETER WAS REMOVED, AND THE INJECTION GOLD PROBE WAS CLEANED DUE TO TISSUE BUILD UP ON THE TIP OF THE PROBE. DURING THE CLEANING PROCESS, THE ENTIRE DISTAL GOLD TIP WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTION GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540704 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2024. DURING PREPARATION, THE TIP OF GOLD PROBE WAS DISLODGED FROM CATHETER WHEN REMOVED FROM PACKAGING. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102826 ↗
• InjuryDec 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN THE UPPER GI TRACT DURING GASTROSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE PROBE WAS PASSED THROUGH THE GASTROSCOPE TO THE DESIRED LOCATION IN THE UPPER PART OF THE VENTRICLE. THE OPERATOR WANTED TO PULL THE NEEDLE IN TO RETRACT THE PROBE UP THE SCOPE, BUT IT BECAME VISIBLE THAT THE TIP OF PROBE WITH THE NEEDLE WAS ABOUT TO RELEASE FROM THE REST OF THE PROBE. INSTEAD OF PULLING THE PROBE INTO THE WORKING CHANNEL AND RISKING THE TIP DETACHING, THE OPERATOR CHOSE TO SLOWLY PULL THE ENTIRE SCOPE BACK. WHEN THEY REACHED THE PHARYNX, ABOUT 3CM OF THE DISTAL NEEDLE PROBE DETACHED. THE DETACHED PIECE WAS REMOVED WITH MCGILLS FORCEPS, AND THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTION GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20985528 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE NEEDLE WAS DEPLOYED, THE TIP CAME OFF. THE TIP DID NOT FALL INTO THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756949 ↗