Gold Probe M00560100Recalls & reported problems
Boston Scientific Corporation · Bipolar Electrohemostasis Catheter · Class 2
All models of Gold Probe (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729174684), received between Jul 30, 2020 and Nov 21, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryMay 13, 2024Detachment 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) 2024. DURING THE PROCEDURE, THE PHYSICIAN EXTENDED THE GOLD PROBE THROUGH THE SCOPE CHANNEL AND OUT OF THE END OF THE SCOPE. UPON MANEUVERING, THE TIP END OF THE GOLD PROBE FELL OFF. THE TIP FELL INSIDE THE PATIENT AND WAS REMOVED USING A NET. ANOTHER GOLD PROBE 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 19296981 ↗MalfunctionJul 30, 2020Detachment 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) 2020. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE TIP OF THE GOLD PROBE FELL OFF. THE DETACHED TIP WAS WITHDRAWN THROUGH SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GOLD PROBE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON OCTOBER 12, 2020** BASED ON THE INFORMATION RECEIVED, THE DISTAL GOLD TIP SEPARATED FROM THE CATHETER AND REMAINED PARTIALLY ATTACHED TO THE DEVICE, BUT COMPLETELY DETACHED UPON REMOVAL OUTSIDE OF THE PATIENT. THE DISTAL GOLD TIP DID NOT FALL INSIDE THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10347013 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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