Hedgehog SBD-291Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840253114037), received between Jun 11, 2020 and Nov 20, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING SCOPE CLEANING PERFORMED ON (B)(6) 2025. WHILE CLEANING THE SCOPE, THE BRUSH PASSED THROUGH THE WORKING CHANNEL WITHOUT ISSUE. HOWEVER, DURING THE SECOND PASS THROUGH THE ASPIRATION CHANNEL, RESISTANCE WAS ENCOUNTERED AND REMOVAL BECAME DIFFICULT. AFTER THE BRUSH WAS FULLY WITHDRAWN, ITS TIP WAS FOUND TO BE MISSING. THE USER THEN SWITCHED TO A REUSABLE METAL BRUSH. WHEN THE REUSABLE BRUSH PASSED THROUGH CHANNEL, THE TIP OF THE HEDGEHOG BRUSH WAS RETRIEVED. THE SCOPE CLEANING WAS COMPLETED USING THE REUSABLE METAL BRUSH. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607534 ↗
• MalfunctionApr 28, 2025Break; Use of Device Problem; Material Integrity Problem; Break; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG BRUSH WAS USED DURING A SCOPE CLEANING PERFORMED ON (B)(6), 2025. THE HEDGEHOG BRUSH WAS USED MULTIPLE TIMES AT THE HOSPITAL'S DISCRETION. AN EVENT OCCURRED IN WHICH THE MOLDED BRUSH PART WAS SEPARATED AND BECAME STUCK INSIDE THE SCOPE. THE SCOPE WAS SENT FOR REPAIR TO REMOVE THE BRUSH FRAGMENT. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. THE HEDGEHOG DIRECTIONS FOR USE (DFU), SPECIFY 'DO NOT REUSE' AND 'MECHANICAL INTEGRITY MAY BE COMPROMISED BY REUSE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920654 ↗
• MalfunctionMar 10, 2025Break; Use of Device Problem; Difficult to Advance; Break; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2025. DURING THE PROCEDURE, THE HEDGEHOG SWEEPER WAS ADVANCED; HOWEVER, RESISTANCE WAS FELT AT THE JUNCTION AROUND TWENTY CENTIMETERS FROM THE FORCEPS PORT. DESPITE THE PROBLEM, THE DEVICE WAS PUSHED FORWARD AND THE TIP BROKE OFF. IT IS UNKNOWN HOW THE DETACHED BRUSH WAS RETRIEVED, AND THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. THE INSTRUCTIONS FOR USE (IFU), ENDOSCOPE CHANNELS MAY BE DAMAGED IF BRUSHES ARE FORCED THROUGH WHEN CHANNELS ARE OCCLUDED OR IF RESISTANCE IS MET DURING BRUSH PASSAGE. IF SHARP BENDS IN PLASTIC SHEATH OR WIRE CABLE ARE OBSERVED DURING INSERTION, DISPOSE OF BRUSH TO AVOID DAMAGING THE ENDOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563589 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE HEDGEHOG SWEEPER BRUSH CAME OFF AND FELL INTO THE SCOPE. REPORTEDLY, THE DETACHED BRUSH WAS ABLE TO BE RETRIEVED SUCCESSFULLY, AND THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 13, 2025. THE BRUSH SHEATH WAS INSERTED, AND THE DETACHED BRUSH WAS PUSHED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127112 ↗
• MalfunctionJul 31, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING A SCOPE CLEANING ON (B)(6) 2024. DURING SCOPE CLEANING, THE WHITE BALL TIP ATTACHED TO THE TIP BRUSH WAS SCRAPED OFF. IT WAS REMOVED FROM 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 19872410 ↗
• MalfunctionAug 18, 2023Difficult 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 DURING A SCOPE CLEANING ON (B)(6) 2022. DURING SCOPE CLEANING, THE HEDGEHOG LONG BRUSH SIDE BECAME CAUGHT AND COULD NOT BE RELEASED, DESPITE MULTIPLE ATTEMPTS. THE ENDOSCOPE WAS SHIPPED TO OLYMPUS FOR REPAIR, WHICH IS EXPECTED TO TAKE SOME TIME. THE PHYSICIAN STATED THAT THE CAUSE IS UNKNOWN AT THIS TIME, BUT PROBABLE FLAWS COULD RESULT IN REPAIR COSTS. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT. INVESTIGATION RESULTS REVEALED THE BRUSH WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT (SEE BLOCK H10 FOR INVESTIGATION DETAILS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577342 ↗
• MalfunctionNov 17, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEARING, THE WHITE BALL TIP OF THE BRUSH DETACHED AND CLOGGED THE SCOPE CHANNEL. SCOPE CLEANING WAS COMPLETED USING ANTHER HEDGEHOG SWEEPER BRUSH. REPORTEDLY, THE SCOPE WAS SENT FOR REPAIR AND THE TIP OF THE BRUSH WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10851671 ↗
• MalfunctionJul 14, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING NASAL ENDOSCOPE CLEANING, THE BRUSH GOT STUCK INSIDE THE ENDOSCOPE CHANNEL. WHEN THE BRUSH WAS REMOVED, IT WAS FOUND THAT THE TIP OF THE BRUSH WAS MISSING. ANOTHER HEDGEHOG SWEEPER BRUSH WAS USED TO COMPLETE THE CLEANING. REPORTEDLY, LEAK TEST WAS PERFORMED AND THE SCOPE IS USED CONTINUOUSLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10272174 ↗
• MalfunctionJun 11, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG SWEEPER BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING SCOPE CLEANING, RESISTANCE IS MET DURING DEVICE USAGE. UPON INSPECTION, THE WIRE AT THE TIP OF THE BRUSH WAS NOTED TO BE PROTRUDING. SCOPE CLEANING WAS COMPLETED USING ANOTHER HEDGEHOG SWEEPER BRUSH THERE WAS NO PATIENT INVOLVEMENT WITH 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. ***ADDITION INFORMATION RECEIVED AS OF SEPTEMBER 07, 2020*** THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOTICED DURING UNPACKING OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10143880 ↗