Blox™ SBT-321Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840253108838), received between Mar 11, 2021 and May 13, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 11, 2021Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BITE BLOX WAS USED DURING AN UPPER ENDOSCOPY, INCLUDING GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BITE BLOX WAS BROKEN INTO SEVERAL PIECES BY PATIENT'S FRONT TEETH AND THE HOSE OF THE GASTRIC CAMERA AS WELL AS THE SCOPE CHANNEL WERE FLATTENED. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT'S MOUTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCOPE AND 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 11467002 ↗