Hedgehog SBD-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00840253114051), received between Feb 11, 2019 and Jul 29, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074260 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073697 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2026. DURING THE CLEANING PROCESS, THE BRISTLES OF THE BRUSH BEGAN TO DETACH WHILE THE ENDOSCOPE WAS BEING CLEANED. IT WAS INDICATED THAT THE BRUSH HAD BEEN PREVIOUSLY USED. THE BRISTLES STARTED FALLING OUT WHILE CLEANING THE THIRD SCOPE. THE CLEANING PROCEDURE WAS COMPLETED USING ANOTHER BRUSH OF THE SAME MODEL. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844610 ↗
• MalfunctionApr 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2026. DURING THE CLEANING PROCESS, THE BRISTLES OF THE BRUSH BEGAN TO DETACH WHILE THE ENDOSCOPE WAS BEING CLEANED. IT WAS INDICATED THAT THE BRUSH HAD BEEN PREVIOUSLY USED. THE BRISTLES STARTED FALLING OUT WHILE CLEANING THE THIRD SCOPE. THE CLEANING PROCEDURE WAS COMPLETED USING ANOTHER BRUSH OF THE SAME MODEL. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834990 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING CLEANING ON (B)(6) 2025. DURING SCOPE CLEANING, THE BRUSH GOT SEPARATED AND FELL OFF. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922142 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2025. WHILE CLEANING THE UPPER ENDOSCOPE, THE BRUSH WAS INSERTED THROUGH THE FORCEPS CHANNEL AND PULLED TOWARDS THE DISTAL TIP. UPON REMOVAL, APPROXIMATELY HALF OF THE BRUSH BRISTLES HAD DETACHED. THE SCOPE CLEANING WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887972 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2025. WHILE CLEANING THE UPPER ENDOSCOPE, THE BRUSH WAS INSERTED THROUGH THE FORCEPS CHANNEL AND PULLED TOWARDS THE DISTAL TIP. UPON REMOVAL, APPROXIMATELY HALF OF THE BRUSH BRISTLES HAD DETACHED. THE SCOPE CLEANING WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887971 ↗
• MalfunctionOct 29, 2025Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE- END BRUSH WAS USED FOR SCOPE CLEANING AFTER COMPLETING A PROCEDURE ON AN UNKNOWN DATE. DURING THE SCOPE CLEANING, HEDGEHOG BRUSH BECAME LODGED NEAR THE FORCEPS CHANNEL AND COULD NOT BE REMOVED. THE SCOPE WAS SUBSEQUENTLY SENT TO OLYMPUS FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THERE WERE BRUSH BRISTLES MISSING FROM BOTH ENDS OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413374 ↗
• InjuryJun 17, 2025Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO THE ONE HEDGEHOG DOUBLE-END BRUSH USED DURING SCOPE CLEANING AND PRIOR PROCEDURE RETAINED IN THE SCOPE. REFER TO MANUFACTURER REPORT# 3005099803-2025-02766 FOR THE HEDGEHOG DOUBLE-END BRUSH (DEVICE MALFUNCTION REPORT) AND FOR THE HEDGEHOG DOUBLE-END BRUSH (SERIOUS INJURY REPORT). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2025. DURING SCOPE CLEANING, THE TIP OF THE BRUSH BROKE OFF AND REMAINED LODGED INSIDE THE BRONCHOSCOPE. THE TECH WAS CLEANING AND DID NOT NOTICE THE BROKEN BRUSH UNTIL THE REPROCESSING WAS FINISHED. THE BRONCHOSCOPE WAS PUT THROUGH THE OER (OLYMPUS ENDOSCOPE PREPROCESSOR) MACHINE AND NOTHING WAS DETECTED EITHER. THE SCOPE WAS THEN HUNG CLEAN AND WAS USED ONTO THE NEXT PATIENT. DURING SET UP FOR THE CASE THEY EXPERIENCED NO PROBLEMS WITH THE SCOPE. THEN, THE TIP OF THE BRUSH THAT WAS LODGED INSIDE THE BRONCHOSCOPE, ENDED UP FALLING INSIDE THE PATIENT. IN THE PHYSICIAN'S OPINION, THE PATIENT DEVELOPED AN INFECTION AND REQUIRED A FOLLOW-UP PROCEDURE TO REMOVE THE BRUSH THAT HAD BEEN LEFT INSIDE. REPORTEDLY, THE PHYSICIAN WAS NOT SURE WHY HE MISSED THE BROK

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 22240783 ↗
• MalfunctionJun 17, 2025Break; Entrapment of Device; Break; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO THE ONE HEDGEHOG DOUBLE-END BRUSH USED DURING SCOPE CLEANING AND PRIOR PROCEDURE RETAINED IN THE SCOPE. REFER TO MANUFACTURER REPORT# FOR THE HEDGEHOG DOUBLE-END BRUSH (DEVICE MALFUNCTION REPORT) AND 3005099803-2025-02767 FOR THE HEDGEHOG DOUBLE-END BRUSH. (SERIOUS INJURY REPORT) IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2025. DURING SCOPE CLEANING, THE TIP OF THE BRUSH BROKE OFF AND REMAINED LODGED INSIDE THE BRONCHOSCOPE. THE TECH WAS CLEANING AND DID NOT NOTICE THE BROKEN BRUSH UNTIL THE REPROCESSING WAS FINISHED. THE BRONCHOSCOPE WAS PUT THROUGH THE OER (OLYMPUS ENDOSCOPE REPROCESSOR) MACHINE AND NOTHING WAS DETECTED EITHER. THE SCOPE WAS THEN HUNG CLEAN AND WAS USED ONTO THE NEXT PATIENT. DURING SET UP FOR THE CASE THEY EXPERIENCED NO PROBLEMS WITH THE SCOPE. THEN, THE TIP OF THE BRUSH THAT WAS LODGED INSIDE THE BRONCHOSCOPE, ENDED UP FALLING INSIDE THE PATIENT. IN THE PHYSICIAN'S OPINION, THE PATIENT DEVELOPED AN INFECTION AND REQUIRED A FOLLOW-UP PROCEDURE TO REMOVE THE BRUSH THAT HAD BEEN LEFT INSIDE. REPORTEDLY, THE PHYSICIAN WAS NOT SURE WHY HE MISSED THE BROKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236229 ↗
• MalfunctionMay 15, 2025Difficult to Remove; Use of Device Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Use of Device Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DUAL END BRUSH WAS USED FOR SCOPE CLEANING FOLLOWING AN UPPER GASTROINTESTINAL TRACT PROCEDURE ON (B)(6) 2024. THE BRUSH WAS INSERTED THROUGH THE FORCEPS CHANNEL OF THE ENDOSCOPE AND PULLED APPROXIMATELY 90CM FROM THE TIP OF THE SCOPE. AT THIS POINT, THE BRUSH BECAME STUCK AND COULD NOT BE MOVED, EITHER BY PULLING OR PUSHING. THE SCOPE WAS SENT FOR REPAIR TO REMOVE THE BRUSH, AND THE SCOPE CLEANING COULD NOT BE COMPLETED. IT WAS REPORTED THIS BRUSH HAD BEEN REUSED PRIOR TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. THE HEDGEHOG DIRECTIONS FOR USE (DFU), SPECIFY 'DO NOT REUSE' AND 'MECHANICAL INTEGRITY MAY BE COMPROMISED BY REUSE'. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THERE WERE BRUSH BRISTLES MISSING FROM BOTH ENDS OF THE DEVICE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030867 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON AN UNKNOWN DATE. THE BRUSH TIP BROKE OFF WHILE CLEANING THE FORCEPS OPENING OF THE ENDOSCOPE. THE SCOPE CLEANING WAS COMPLETED USING THE SAME HEDGEHOG DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594390 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING ON AN UNKNOWN DATE. AFTER USING THIS PRODUCT TO CLEAN THE FORCEPS OPENING OF THE ENDOSCOPE, THE TIP BROKE OFF. THE SCOPE CLEANING WAS COMPLETED USING THE SAME HEDGEHOG DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584860 ↗
• MalfunctionJan 12, 2023Break; Break

  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 TIP OF THE BRUSH WAS DAMAGED AND WAS LEFT BEHIND IN THE ENDOSCOPE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147906 ↗
• MalfunctionDec 20, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED ON AN UNKNOWN DATE. DURING SCOPE CLEANING, THE BRUSH PART CAME OFF. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013552 ↗
• MalfunctionNov 10, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A SCOPE CLEANING PERFORMED ON (B)(6) 2022. DURING SCOPE CLEANING, THE LITTLE BRUSH FELL APART WHEN CLEANING THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HEDGEHOG DOUBLE-END BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT. A PHOTO PROVIDED SHOWED THE LARGE AND SMALL BRUSH HEAD BENT AND APPEARED TO SHOW BRISTLES DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776974 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEANING, ALL THE BRISTLES ON ONE END OF THE BRUSHES DETACHED. NO SCRATCH OR DAMAGE WAS NOTED ON THE ENDOSCOPE. REPORTEDLY, ANOTHER OF THE SAME HEDGEHOG BRUSH WAS USED TO SWEEP THE BRISTLES FOUND IN THE SCOPE AND COMPLETED THE SCOPE CLEANING. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10720035 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED ON JANUARY 15, 2019. ACCORDING TO THE COMPLAINANT, DURING SCOPE REPROCESSING, THE BRISTLES FROM THE HEDGEHOG BRUSH DETACHED IN THE SCOPE. THE BRISTLES WERE REMOVED MANUALLY FROM THE SCOPE. IT WAS REPORTED THAT ANOTHER HEDGEHOG BRUSH WAS USED TO COMPLETE SCOPE CLEANING. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8329495 ↗