Gold ProbeRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 2 models of Gold Probe by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 24, 2026 — classified as 14 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 Gold Probe problems
Device problems
- Detachment of Device or Device Component30
- Failure to Deliver Energy9
- Adverse Event Without Identified Device or Use Problem5
- Detachment Of Device Component2
- Material Separation2
- Use of Device Problem2
- Component Missing1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient3
Gold Probe models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gold Probe M00560070Unit, electrosurgical, endoscopic (with or without accessories)43 reports
- Gold Probe M00560100Unit, electrosurgical, endoscopic (with or without accessories)4 reports
Recent Gold Probe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Detachment of Device or Device Component
It was reported to Boston Scientific Corporation that a Gold Probe was intended to be used for a Hemostasis during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026. During the procedure, the device exhibited a condition where the gold tip of the gold probe fell off the catheter after electrocoagulation. The distal gold tip fell into the patient. The physician grabbed the gold tip of the probe out with the use of a forceps. The procedure was completed with the original device.The patient condition following the procedure was reported as stable, and no patient complications were reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887081 ↗MalfunctionFeb 13, 2026Inability to Irrigate; Nonstandard Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE HEMOSTASIS CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, IT WAS REPORTED THAT THERE IS NO WATER FLOW THROUGH THE CHANNEL, WHICH COMPROMISES THE PROPER USE OF THE DEVICE. ALSO, A VISUAL IRREGULARITY WAS OBSERVED AT THE TIP OF THE ELECTRODE, AS WELL AS A SLIGHTLY YELLOWISH APPEARANCE OF THE MATERIAL. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332299 ↗InjuryNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS NOT OPERATING PROPERLY. WHEN THE GOLD PROBE WAS REMOVED, THE TIP FELL OFF INTO THE PATIENT. A NET WAS USED TO REMOVE THE DETACHED TIP. 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 23623491 ↗InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GOLD PROBE FELL OFF IN THE PATIENT. THE TIP OF THE DEVICE WAS RETRIEVED USING A RAT TOOTH. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 10, 2025. THE ANATOMY LOCATION WAS COLON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23489638 ↗MalfunctionOct 17, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS EVIDENT THAT THE TOP OF THE GOLD PROBE HAD DETACHED INSIDE THE PATIENT. IT WAS UNKNOWN HOW WAS THE TIP OF THE DEVICE RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323392 ↗MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO 3005099803-2025-05331 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE SNAPPED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321534 ↗MalfunctionOct 17, 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
NOTE: THIS REPORT PERTAINS TO TWO OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05330 FOR THE FIRST GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE GOLD PROBE SNAPPED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321523 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ENTIRE DISTAL GOLD TIP DETACH FROM THE END OF THE CATHETER BUT DIDN'T FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293858 ↗MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED DURING A HEMOSTASIS PROCEDURE ON (B)(6), 2025. DURING THE PROCEDURE, THE TIP FELL OFF IN PATIENT AND GET DETACHED FROM THE END OF THE CATHETER. IT WAS RETRIEVED USING THE NET. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993111 ↗MalfunctionSep 8, 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 A GOLD PROBE WAS USED DURING A HEMOSTASIS PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP FELL OFF IN PATIENT AND GET DETACHED FROM THE END OF THE CATHETER. IT WAS RETRIEVED USING THE NET. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993110 ↗InjurySep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE DUODENUM DURING HEMOSTASIS PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP BECAME SEPARATED. THE TIP WAS RETRIEVED USING TISSUE CLIPS. THE PROCEDURE WAS COMPLETED USING ANOTHER GOLD PROBE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22955813 ↗InjuryJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE WAS USED IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DEVICE WAS USED TO CAUTERIZE, AND THE DISTAL GOLD TIP DETACHED INSIDE THE PATIENT. A NON-BSC RETRIEVAL DEVICE WAS USED TO RETRIEVE THE TIP. 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 22202667 ↗MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER: 3005099803-2024-06777 FOR THE FIRST GOLD PROBE, AND 3005099803-2024-06778 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GOLD PROBE DEVICES WERE USED DURING AN UPPER GI ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE DISTAL TIP OF THE TWO GOLD PROBE NEEDLES BROKE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102855 ↗MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-06778 FOR THE SECOND GOLD PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO GOLD PROBE DEVICES WERE USED DURING AN UPPER GI ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PROCEDURE, THE DISTAL TIP OF THE TWO GOLD PROBE NEEDLES BROKE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102823 ↗MalfunctionDec 13, 2024
TWO DIFFERENT GOLD PROBE ELECTRICAL CONNECTORS: THE TIPS BROKE OFF --OUTSIDE OF THE PATIENT. 1. LOT# 34679528, EXP. 8/21/2026. 2. LOT# 33590221, EXP. 3/8/2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924285 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 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.
How reports and recalls are matched · Editorial policy · Report an error on this page