Hedgehog SBB-382Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840253114020), received between Sep 18, 2018 and Sep 4, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619134 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374586 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2026. WHILE CLEANING THE ERCP SCOPE, THE BRUSH HEAD DETACHED AND ITS BRISTLES BECAME LODGED IN THE SCOPE. THE BRISTLES WERE SUCCESSFULLY RETRIEVED FROM THE SCOPE, AND THE CLEANING PROCESS WAS THEN COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821494 ↗
• MalfunctionApr 9, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2025. DURING A SCOPE CLEANING, THE TIP OF THE BRUSH DETACHED AND REMAINED STUCK IN THE FORCEPS CHANNEL OF THE ENDOSCOPE. THE TIP WAS RETRIEVED USING ANOTHER CLEANING BRUSH AND FLUSHING WITH WATER. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809113 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BUNDLE WAS USED DURING A SCOPE CLEANING PERFORMED ON (B)(6) 2025. DURING THE SCOPE CLEANING, IT WAS NOTICED THAT THE BRISTLED PORTION OF THE BRUSH DETACHED INSIDE THE SUCTION VALVE UPON REMOVAL. THE DETACHED BRISTLE WAS RETRIEVED SUCCESSFULLY. THE SCOPE CLEANING WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584826 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE BRISTLES ON ONE SIDE OF THE DOUBLE END BRUSH BROKE. THE BRISTLES WERE NOT REMOVED FROM THE SCOPE. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009168 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THEY NOTICED THAT THE BRUSH DID NOT CAME OUT FROM THE TIP OF THE SCOPE. THEY REALIZED THAT THE BRUSH DETACHED INSIDE THE SCOPE. SEVERAL FLUSHES FROM ALL PORTS WERE DONE AND A TRADITIONAL METAL BRUSH WAS USED TO RETRIEVE THE BROKEN TIP. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805817 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE BRUSH DETACHED INSIDE THE SCOPE. THE BRISTLE WAS REMOVED USING A GRASPING FORCEPS. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610079 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE BRUSH DETACHED INSIDE THE SCOPE. THE BRISTLE WAS REMOVED USING A GRASPING FORCEPS. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609965 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE BRUSH BRISTLE BROKE. THE BRISTLE WAS REMOVED USING FORCEPS. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970311 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BUNDLE WAS USED DURING A SCOPE CLEANING PERFORMED ON (B)(6) 2023. DURING THE CLEANING OF DUODENOSCOPE, THE BRUSH DETACHED FROM THE CLEAR PLASTIC HANDLE. THE DETACHED BRUSH WAS RETRIEVED BY HAND. THE SCOPE CLEANING WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851980 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2023. DURING THE SCOPE CLEANING, THE END OF THE CLEANING BRUSH BROKE OFF INSIDE THE ENDOSCOPE. THE DETACHED BRUSH WAS RETRIEVED BY PUSHING ANOTHER BRUSH THROUGH THE SCOPE. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699788 ↗
• MalfunctionJan 4, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2022. DURING SCOPE CLEANING THE END OF THE CLEANING BRUSH BROKE OFF INSIDE OF THE ENDOSCOPE. THE ENDOSCOPE WAS SENT FOR REPAIR IN ORDER TO RETRIEVE THE END OF THE BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094079 ↗
• MalfunctionOct 14, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED ON AN UNKNOWN DATE. DURING SCOPE CLEANING, THE BRUSH BROKE AND WAS STUCK INSIDE THE ENDOSCOPE. THE ENDOSCOPE WAS SENT FOR REPAIR TO RETRIEVE THE BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607195 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. DURING SCOPE CLEANING, THE STUBBY BRUSH OR SMALLER BRUSH BROKE. THE DETACHED BRUSH WAS RETRIEVED FROM THE SCOPE WITH HAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER HEDGEHOG DOUBLE-END BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515266 ↗
• MalfunctionSep 9, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BUNDLE WAS USED FOR SCOPE CLEANING ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEANING, THE BRUSH HEAD OF THE DOUBLE END CHANNEL BRUSH DISLODGED FROM THE HANDLE AND GOT STUCK IN THE BIOPSY CHANNEL. THE BRUSH HEAD WAS THEN REMOVED BY PUSHING IT OUT OF THE SCOPE USING BIOPSY FORCEPS. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG DOUBLE BUNDLE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448865 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BUNDLE WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. AFTER THE SCOPE AND CLEANING TRAY WENT THROUGH THE REPROCESSING MACHINE, A BRUSH BRISTLE WAS FOUND ON THE TRAY. THE BRISTLE WAS REMOVED BY WASHING THE TRAY. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694446 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, AFTER THE SCOPE WENT THROUGH THE REPROCESSING MACHINE, A BRISTLE WAS FOUND ON THE TIP OF THE SCOPE. THE BRISTLE WAS WIPED OFF WITH GAUZE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694441 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BOUNDLE WAS USED DURING A SCOPE CLEANING PERFORMED ON AN UNKNOWN DATE. AFTER THE SCOPE WENT THROUGH THE REPROCESSING MACHINE, A BRUSH BRISTLE WAS FOUND ON THE NUMBER PLATE OF THE SCOPE. THE BRISTLE WAS REMOVED BY WIPING OFF WITH GAUZE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694436 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE SCOPE CLEANING, THE BRISTLES WERE STUCK ON THE BUTTON. THE TECHNICIAN REMOVED THE BRISTLES FROM THE BUTTON BY HAND. SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 11166022 ↗
• MalfunctionSep 17, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEANING, THE BRUSH WAS DETACHED AND A BRISTLE WAS LEFT INSIDE THE SCOPE. A PAIR OF FORCEPS WAS USED TO REMOVE THE BRISTLE FROM THE SCOPE. THE SCOPE CLEANING WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10546807 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEANING, THE BRISTLES OF THE BRUSH DETACHED AND GOT STUCK IN TO THE SCOPE VALVES. THE BRISTLES WERE REPORTED TO HAVE BEEN REMOVED MANUALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9437900 ↗
• MalfunctionNov 5, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DUAL-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE BRISTLES BROKE OFF IN THE SCOPE CHANNEL. ANOTHER BRUSH WAS USED TO COMPLETE THE CLEANING OF THE SCOPE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED AS OF 07NOV2019. THE BRISTLES WERE REMOVED BY PUSHING IT OUT OF THE SCOPE CHANNEL.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9278735 ↗
• MalfunctionSep 9, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DUAL-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHILE CLEANING THE SCOPE, THE CATHETER BROKE CAUSING THE BRUSH TO DETACH INSIDE THE WORKING CHANNEL OF THE SCOPE. THE BRUSH WAS REMOVED FROM THE SCOPE. IT IS UNKNOWN HOW THE SCOPE CLEANING WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8974194 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE BUNDLE BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHILE CLEANING THE SCOPE, BRISTLES DETACHED FROM THE BRUSH HEAD AND GOT CAUGHT IN THE SPRING PART OF THE ASPIRATION BUTTON. IT WAS NOT REPORTED HOW THE DETACHED BRISTLES WERE REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8631821 ↗