Blox™ SBT-546Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840253104816), received between Jul 2, 2019 and Jul 27, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 6, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITEBLOX DEVICE WAS BEING PREPARED FOR USE IN A PROCEDURE ON (B)(6), 2023 UPON OPENING THE DEVICE PACKAGE DURING PREPARATION, A HAIR WAS NOTED INSIDE THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070645 ↗
• MalfunctionApr 27, 2021Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BLOX BITE BLOCK WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BITE BLOX WAS BROKEN INTO PIECES. NO DEBRIS WERE FOUND INSIDE THE PATIENT'S MOUTH AND THE BROKEN PIECES WAS RETRIEVED BY HAND. 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 11734154 ↗
• InjuryDec 2, 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 (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ALLERGIC REACTION TO THE ELASTIC OF THE BITE BLOX. REPORTEDLY, THE PATIENT APPEARS TO HAVE PRE-EXISTING ALLERGIES TO EITHER POLYESTER OR POLY URETHANE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ***ADDITIONAL INFORMATION AS OF 26DEC2019*** THE ALLERGIC REACTION WAS LIKE A RASH AROUND THE AREAS WHERE THE BITE BLOX CAME INTO CONTACT WITH THE SKIN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9395795 ↗
• MalfunctionJul 2, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOCK WAS USED FOR AN ENDOSCOPIC PROCEDURE, ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THERE WAS A HAIR INSIDE OF THE DEVICE PACKAGE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754931 ↗