Blox™ SBT-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00840253108821), received between May 20, 2019 and Jul 6, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (20 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 26 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 5, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER ENDOSCOPY IN THE UPPER GASTROINTESTINAL TRACT PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE THE PATIENT WEARING THE BITEBLOX, THE PATIENT BIT OFF THE BITEBLOX WHILE ACTING VIOLENTLY. AS A RESULT, THERE WAS A TEAR IN THE ORAL CAVITY AND ORAL BLEEDING. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 18838347 ↗
• MalfunctionFeb 12, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2024. WHEN THE PATIENT YAWNED, A SMALL PIECE OF BITE BLOX BROKE OFF AND WAS NOTICED BEFORE PUTTING THE SCOPE INTO THE PATIENT'S MOUTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITE BLOX. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687119 ↗
• MalfunctionDec 6, 2023Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER GASTROINTESTINAL ENDOSCOPY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE ENDOSCOPE WAS INSERTED A SNAPPING SOUND WAS HEARD. A BROKEN PIECE WAS FOUND INSIDE THE MOUTH AND RECOVERED. THERE WERE NO ORAL LACERATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITE BLOX. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273498 ↗
• MalfunctionApr 27, 2023Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ORAL ENDOSCOPY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE MOUTHPIECE GOT BITTEN STRONGLY BY THE PATIENT AND CRACKED INCLUDING THE RIM PART. THERE IS A CRACK IN THE MAIN BODY. THE ENDOSCOPE ALSO GOT BITTEN AND DAMAGED. IT WAS NOT REPORTED HOW WAS THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824734 ↗
• MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED ON (B)(6), 2022. DURING PREPARATION, A BLACK DIRT WAS ADHERED INTO THE UNUSED MOUTHPIECE. 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 15156618 ↗
• MalfunctionMay 18, 2022Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BLOX ENDOSCOPIC BITE BLOCK WAS USED DURING A TREATMENT FOR STOMACH PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PATIENT HAD HIS MOUTHPIECE DAMAGED BY HIS TOOTH THROUGH A GASTRIC CAMERA WHILE SEDATED. THE BROKEN FRAGMENTS FELL OUTSIDE OF THE PATIENT'S MOUTH. THE PROCEDURE COMPLETED USING THE ORIGINAL BITE BLOCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428235 ↗
• MalfunctionJan 28, 2022Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ENDOSCOPY PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE ENDOSCOPE WAS INSERTED, A PART OF THE BITE BLOX WAS CHIPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BITE BLOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387517 ↗
• MalfunctionJun 30, 2021Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BITE BLOX WAS CHEWED BY THE PATIENT. IT WAS NOTED THAT THERE WAS A CRACK IN THE BOTTOM PART WHERE THE FRONT TEETH HITS. REPORTEDLY, THE BROKEN PIECED DETACHED OUTSIDE OF THE BODY. THE PROCEDURE WAS COMPLETED WITH THE 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 12091541 ↗
• MalfunctionOct 8, 2020Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING BIOPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE WAS COMPLETED, IT WAS NOTED THAT THE BITE BLOX WAS BROKEN. DEBRIS WERE FOUND INSIDE THE PATIENT'S MOUTH AND WERE RETRIEVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL BITE BLOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10651057 ↗
• MalfunctionJul 9, 2020Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT MOVED AND BROKE THE MOUTH PIECE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL BITE BLOX. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254338 ↗
• MalfunctionMay 7, 2020Contamination; Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS ABOUT TO BE USED ON A PROCEDURE, ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THE BITE BLOX WAS DIRTY. ANOTHER BITE BLOCK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS 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 Consequences Or Impact To Patient

  MAUDE report 10032521 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT'S MOUTH WAS MOVING, A SNAPPING SOUND WAS HEARD. UPON CHECKING, THE DEVICE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. A SMALL AMOUNT OF BLEEDING IN THE PATIENT'S MOUTH WAS NOTED, BUT THE BLEED WAS MINOR AND REPORTEDLY DID NOT REQUIRE ANY TREATMENT. NO OTHER PATIENT COMPLICATIONS REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9596415 ↗
• MalfunctionJan 2, 2020Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BLOX BITE BLOCK WAS USED IN THE MOUTH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER PLACING THE BITE BLOCK IN THE PATIENT'S MOUTH AND AFTER SEDATION, THE PATIENT BIT DOWN AND THE BITEBLOX BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER BITE BLOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9540118 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, A DAY AFTER THE PROCEDURE, THE PATIENT HAD AN ALLERGIC REACTION TO THE BITE BLOX. REPORTEDLY, THE PATIENT WAS HAVING FEVER AND HAD BLISTERS AND SORES AROUND THE MOUTH AREA. 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: Fever; Hypersensitivity/Allergic reaction; Injury

  MAUDE report 9086308 ↗
• MalfunctionSep 11, 2019Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BITE BLOX BROKE WHILE INSIDE THE PATIENT'S MOUTH. REPORTEDLY, NO DEVICE FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL BITE BLOX DEVICE. THE COMPLAINANT REPORTED THAT THE PATIENT'S MOUTH WAS SLIGHTLY CUT FOLLOWING THE PROCEDURE, BUT NO ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE CUT. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 8996885 ↗