HedgehogRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 190
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of Hedgehog by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Sep 7, 2026 — classified as 6 injuries, 184 malfunctions.
The most frequently reported specific device problem is “Break” (172 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hedgehog problems
Device problems
- Break172
- Entrapment of Device18
- Material Integrity Problem16
- Adverse Event Without Identified Device or Use Problem12
- Defective Device9
- Difficult to Advance4
- Difficult to Remove4
- Use of Device Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions142
- No Patient Involvement35
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
- Foreign Body In Patient1
- Laceration(s)1
- Unspecified Infection1
Hedgehog models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hedgehog SBD-289ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE129 reports
- Hedgehog SBB-382ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE34 reports
- Hedgehog SBD-228ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE18 reports
- Hedgehog SBD-291ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE9 reports
Recent Hedgehog adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619134 ↗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 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374586 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228382 ↗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 ↗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 ↗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 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 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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