Hedgehog SBD-289Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00840253114044), received between Sep 6, 2018 and Sep 7, 2026 — classified as 5 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Break” (115 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658893 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488964 ↗
• MalfunctionAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410409 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228382 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2026. DURING CLEANING, THE BRUSH CATHETER SNAPPED IN HALF AT THE MIDPOINT OF THE SCOPE. THERE WAS NO RESISTANCE DURING BRUSHING, AND THE TUBING SHOWED NO KINKS OR BENDS. THE REMAINING PORTION OF THE CATHETER WAS SUCCESSFULLY REMOVED FROM THE SCOPE. A NEW BRUSH OF THE SAME DEVICE TYPE WAS USED TO COMPLETE THE CLEANING PROCESS. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT, AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690016 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING SCOPE CLEANING, THE TIP OF THE HEDGEHOG BRUSH 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 23877890 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED ON (B)(6) 2025. DURING SCOPE CLEANING, THE TIP OF THE CLEANING BRUSH BROKE AFTER IT WAS INSERTED INTO AND REMOVED FROM THE SCOPE TWO OR THREE TIMES. 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. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 16, 2025: IT WAS REPORTED THAT THE SCOPE WAS SENT FOR INSPECTION DUE TO THE POSSIBILITY THAT A PART MAY HAVE FALLEN INSIDE. HOWEVER, THE FACILITY CONFIRMED THAT NO FOREIGN OBJECTS WERE FOUND WITHIN THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864532 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED ON (B)(6) 2025. DURING SCOPE CLEANING, THE HEDGEHOG BRUSH HEAD BROKE OFF AND WAS THEN RETRIEVED FROM THE SCOPE. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632511 ↗
• MalfunctionNov 20, 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 SCOPE CLEANING, THE BRISTLES FELL OFF IN THE SINK FROM THE LARGER PORT CHANNEL BRUSH. THE SCOPE CLEANING WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605166 ↗
• MalfunctionNov 19, 2025Break; 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 DOUBLE-END BRUSH WAS USED ON (B)(6) 2025. DURING SCOPE CLEANING, THE HEDGEHOG BRUSH HEAD WAS DAMAGED AT THE CONNECTION POINT TO THE VALVE BRUSH. THE SCOPE CLEANING WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THE 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 23593696 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON A UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309109 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON A UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309108 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON A UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309107 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303975 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303411 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON A UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301916 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON A UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301906 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301873 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE HEAD DETACHED FROM THE SMALLER END OF A HEDGEHOG BRUSH DURING SCOPE CLEANING AND WAS SUCCESSFULLY RETRIEVED USING RESCUE FORCEPS. SCOPE CLEANING WAS COMPLETED WITH ANOTHER HEDGEHOG. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301870 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH HEAD WAS FOUND IN A SCOPE'S SUCTION CHANNEL DURING SCOPE CLEANING ON (B)(6) 2025. DURING SCOPE CLEANING, THE NURSE FOUND A BROKEN TIP OF THE BRUSH INSIDE THE SCOPE'S SUCTION CHANNEL NEAR THE AREA WHERE THE CAP IS PLACED. UPON INSPECTION, SHE ILLUMINATED THE INSIDE OF THE SCOPE, NOTICED THE WHITE PART OF THE BRUSH, AND SUCCESSFULLY RETRIEVED IT. THERE WAS NO PATIENT INVOLVEMENT IN THE 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 23167854 ↗
• MalfunctionJul 18, 2025Break; 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 DOUBLE-END BRUSH WAS USED DURING SCOPE CLEANING ON (B)(6) 2025. DURING SCOPE CLEANING, THE BRISTLES OF THE BRUSH WERE LOST. THE SCOPE CLEANING WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543429 ↗
• MalfunctionJun 11, 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, RESISTANCE WAS FELT WHILE INSERTING AND WITHDRAWING THE DEVICE FROM THE ENDOSCOPE. THE TIP BRUSH HAD DETACHED AND REMAINED INSIDE BUT WAS SUCCESSFULLY PUSHED OUT WITH ANOTHER BRUSH, CAUSING NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184563 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG WAS USED DURING A SCOPE CLEANING ON UNKNOWN DATE. REPORTEDLY, THE BRUSH HEAD DETACHED INSIDE THE SCOPE DURING CLEANING. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097945 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG WAS USED DURING A SCOPE CLEANING ON UNKNOWN DATE. REPORTEDLY, THE BRUSH HEAD DETACHED INSIDE THE SCOPE DURING CLEANING. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096711 ↗
• MalfunctionMay 27, 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, TWO BRUSHES BROKE OFF INTO THE CHANNEL END OF A 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 22087930 ↗