BiZact BZ4112Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521552456), received between May 16, 2018 and Jul 7, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Energy Output Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY REPORTED POST-TONSILLECTOMY HEMORRHAGE OUTCOMES IN PATIENTS WHO UNDERWENT BIZACT TONSILLECTOMY BETWEEN JANUARY 2017 AND DECEMBER 2020. THE BIZACT DEVICE WAS USED TO DIVIDE THE TISSUE BETWEEN CONSTRICTOR AND TONSIL. THERE WERE 1059 CHILDREN AND 658 ADULTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED HEMORRHAGE. BLEEDING WITHIN 24 HOURS OCCURRED IN ONE PEDIATRIC PATIENT AND REQUIRED REOPERATION. HEMORRHAGE AFTER 24 HOURS REQUIRED READMISSION FOR OBSERVATION IN 80 PATIENTS, MINOR INTERVENTION WITH OR WITHOUT LOCAL ANESTHESIA IN 9 PATIENTS, REOPERATION IN 11 PATIENTS AND BLOOD TRANSFUSION IN ONE PATIENT. SECONDARY POST-TONSILLECTOMY HEMORRHAGE WAS REPORTED TO BE GREATER IN TRAINEE SURGEONS AND IN ADULTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17279171 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JULY 2016 AND OCTOBER 2019, A STUDY EVALUATED PEDIATRIC PATIENTS (AGE 1-16) WHO UNDERWENT TONSILLECTOMY USING BIZACT. THERE WERE 146 PATIENTS AND COMPLICATIONS INCLUDED: POST-TONSILLECTOMY HEMORRHAGE AND INFECTION. THREE PATIENTS REQUIRED REOPERATION FOR BLEEDING AND HOSPITAL ADMISSION WAS REQUIRED FOR INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 12273585 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS DOING FINE, BUT HAD TO BE ADMITTED ON DAY SEVEN AFTER A SMALL BLEEDING. THERE WAS NO NEED FOR SURGICAL INTERVENTION. THE PATIENT WAS OBSERVED FOR THE NIGHT THEN RELEASED THE FOLLOWING DAY.

  Patient problems: No Information

  MAUDE report 7583283 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT FROM A TONSILLECTOMY CLINICAL TRIAL REPORTED THAT TWO DAYS AFTER A PROCEDURE WHERE THE DEVICE WAS USED, POST-OPERATIVE BLEEDING OCCURRED. THE PATIENT WAS ADMITTED TO THE OR, BUT THE BLEEDING STOPPED AND NO TREATMENT WAS REQUIRED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7518643 ↗