BloxRecalls & reported problems across all models

We found 3 models of Blox by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between May 20, 2019 and Jul 27, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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

Most reported Blox problems

Blox models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Blox™ SBT-114

  Endoscopic bite block
  26 reports
• Blox™ SBT-546

  Endoscopic bite block
  8 reports
• Blox™ SBT-321

  Endoscopic bite block
  2 reports

Recent Blox adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Material Separation

  It was reported to Boston Scientific Corporation that a Bite Blox was used during a procedure performed on (b)(6) 2026. During the procedure, the Bite Blox device broke during use. The procedure was completed using another of the same device. There were no patient complication 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 50025249 ↗
• MalfunctionJul 6, 2026Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED FOR THE LUNGS DURING BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BITE BLOCK WAS PLACED IN THE PATIENTS MOUTH AND THE PATIENT BIT DOWN FORCEFULLY ON THE DEVICE, CAUSING IT TO BECOME DAMAGED. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725412 ↗
• InjuryMay 13, 2026Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED IN THE MOUTH DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A LOUD POPPING SOUND WAS HEARD. IT WAS DISCOVERED THAT THE PATIENT HAD BITTEN DOWN ON THE BITE BLOX, CAUSING A PIECE OF THE BITE BLOX TO BREAK OFF. THE PATIENT REQUIRED FURTHER EVALUATION USING A SECOND BRONCHOSCOPE TO CONFIRM THAT NO FRAGMENT HAD ENTERED THE AIRWAY OR LUNGS. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166441 ↗
• MalfunctionApr 8, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR AN UPPER ENDOSCOPY ON (B)(6) 2026, IT WAS NOTED IN THE UNOPENED BITE BLOX PACKAGE THERE WAS DIRT ON THE WHITE STRAP. THERE WAS NO PATIENT INVOLVEMENT AT THIS TIME. A NEW BITE BLOX WAS OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818361 ↗
• MalfunctionApr 8, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR AN UPPER ENDOSCOPY ON (B)(6) 2026, IT WAS NOTED THAT THERE WAS HAIR INSIDE THE UNOPENED BITE BLOX PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AT THIS TIME. A NEW BITE BLOX WAS OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818357 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BITE BLOX FRACTURED DUE TO EXCESSIVE JAW PRESSURE EXERTED BY THE PATIENT. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778842 ↗
• MalfunctionNov 7, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PART THAT WAS BEING BITTEN BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497294 ↗
• MalfunctionJul 24, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING A PROCEDURE ON UNKNOWN DATE. IT WAS REPORTED THAT THE BITE BLOX WAS FOUND TO BE BROKEN UPON REMOVAL FROM ITS INDIVIDUAL PACKAGING. A NEW DEVICE FROM THE SAME LOT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586335 ↗
• MalfunctionJul 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED ON UNKNOWN DATE. IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITE BLOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543420 ↗
• MalfunctionMay 28, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. DURING THE PROCEDURE, THE BITE BLOX CRACKED AND BROKE INTO TWO PIECES. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098939 ↗
• InjuryFeb 11, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. DURING THE PROCEDURE, A LOUD SNAP WAS HEARD WHEN THE PATIENT BIT DOWN ON THE BITE BLOX. THE DEVICE WAS CHECKED AND APPEARED TO BE INTACT, SO THE CASE WAS CONTINUED. THE PHYSICIAN REPORTED THAT THE PATIENT WAS NOT BREATHING, AND HEART RATE WAS DROPPING; A CODE WAS CALLED. THE PHYSICIAN ATTEMPTED TO ADMINISTER THE ANESTHESIA TO INTUBATE THE PATIENT; A PIECE OF GREEN PLASTIC WAS NOTED IN THE PATIENT'S AIRWAY. THE BROKEN PIECE WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IN THE PHYSICIAN'S ASSESSMENT, THE DEVICE CONTRIBUTED TO THE PATIENT COMPLICATIONS AND IT IS UNKNOWN IF THE PATIENT HAS ANY CO-MORBIDITIES THAT COULD HAVE CONTRIBUTED TO THE EVENT. REPORTEDLY, THE PATIENT WAS NOT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE AND GOT FULLY RECOVERED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Airway Obstruction; Cardiac Arrest; Respiratory Insufficiency

  MAUDE report 21355885 ↗
• MalfunctionAug 1, 2024Material Separation; Material Separation

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT A BITE BLOX WAS USED, DURING A GASTROSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE BITE BLOX GOT CHIPPED. NOTHING DETACHED INSIDE THE PATIENT. IT WAS REPORTED, THE DEVICE WAS NOT INSPECTED, PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITE BLOX. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885887 ↗
• MalfunctionMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND, BITE BLOX WAS DAMAGED/BROKEN. SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233617 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER ENDOSCOPY PERFORMED ON (B)(6) 2024 FOR THE TREATMENT OF ESOPHAGEAL DILATION. DURING THE PROCEDURE, THE BITE BLOCKS BROKE WHEN SCOPE REACHED THE STOMACH FOR VISUALIZATION. THE SCOPE WAS REMOVED FROM THE PATIENT'S MOUTH AND NOTICED THAT A PIECE OF THE BITE BLOCK WAS INSIDE THE PATIENT'S MOUTH WITH TRACES OF BLOOD. THE DETACHED PIECE WAS RETRIEVED BY HAND. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19034502 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE UPPER ENDOSCOPY PERFORMED ON (B)(6) 2024. DURING THE MID-PROCEDURE, THE BITE BLOX BROKE, AND THE PATIENT CHIPPED A TOOTH. THE BROKEN ONE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Tooth Fracture

  MAUDE report 18867295 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports