BiZactRecalls & reported problems across all models

We found 2 models of BiZact by Covidien LP in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 2, 2025 — classified as 1 death, 24 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (8 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 BiZact problems

BiZact models

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

• BiZact BZ4212A

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 death35 reports
• BiZact BZ4112

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  4 reports

Recent BiZact adverse event reports

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

• MalfunctionSep 2, 2025Energy Output Problem; Failure to Cut; Intermittent Energy Output; Energy Output Problem; Failure to Cut; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN OPEN TONSILLECTOMY PROCEDURE; THE DEVICE WAS APPLIED TO THE TONSILS AND EXHIBITED INADEQUATE OR PARTIAL SEALING AND CUTTING ON NORMAL THICKNESS OF TISSUE. THE DEVICE GAVE A SEALING SOUND BUT DID NOT GIVE THE SEAL COMPLETE TONE AND WITH EVIDENCE OF ENERGY DELIVERY. ANOTHER DEVICE WAS SUBSEQUENTLY USED SUCCESSFULLY. PATIENT HAD MINOR BLEEDING AFTER CUTTING AND BLOOD TRANSFUSION WAS NOT NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22937355 ↗
• DeathJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-TONSILLECTOMY PROCEDURE AND FROM AN ADDITIONAL INFORMATION, IT WAS FOUND OUT THAT THE SURGEON HAS USED THE BIZACT DEVICE FOR ABOUT SIX WEEKS. IN THAT TIME, HE HAD THREE BLEEDS. ONE WAS IMMEDIATELY POST-OP THAT HE STOPPED WITH CAUTERY, ONE WITH NO ADDITIONAL DETAIL, AND A PEDIATRIC PATIENT THAT RETURNED AFTER FIVE DAYS TO THE HOSPITAL WITH EXCESSIVE POST-OP BLEEDING AND EVENTUALLY PASSED AWAY DUE TO BLOOD LOSS. A FORCETRIAD WAS USED TOGETHER WITH THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19721361 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT. PHOTO RECEIVED SHOWED THAT THE DEVICE HAD DAMAGED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843122 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843112 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843109 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843080 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843076 ↗
• 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 ↗
• InjuryMay 25, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A POST-OP BLEED AFTER A TONSILLECTOMY DURING A BIZACT TRIAL. HEMOSTASIS WAS ACHIEVED DURING THE PROCEDURE. EVENT OCCURRED ONE DAY AFTER THE SURGERY. WHICH LED TO RE-ADMITTANCE INTO OPERATING ROOM AND EXTENT OF HOSPITALIZATION FOR FEW DAYS. DURING PROCEDURE AN ACTIVATION WAS HEARD, NO RE-GRASP ALERT, AN END-TONE AND ENERGY DELIVERY WAS OBSERVED. PATIENT'S HEALTH HAS IMPROVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17002033 ↗
• InjuryMay 19, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS BROUGHT BACK TO MANAGE A TONSILLECTOMY BLEEDING. THE EVENT EXTEND PATIENT'S HOSPITALIZATION TO ONE DAY. NO TRANSFUSION WAS REQUIRED. RE-OPERATION OR ADDITIONAL SURGICAL PROCEDURES WAS NEEDED. NO ISSUE DURING INTRA-OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14435808 ↗
• 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 ↗
• MalfunctionMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF TONSILLECTOMY, THE PATIENT HAD SEVERE SWELLING OF THE UVULA. THE PATIENT HAD MASSIVE TONSILLAR HYPERTROPHY AND A SMALL UVULA. THE LYMPHATIC DRAINAGE WAS SEALED OFF DURING USED OF THE DEVICE RESULTING IN UVULAR SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 11764344 ↗
• MalfunctionMar 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE NEEDS TO TEST FOR NORMAL OPERATION. THE PATIENT HAD BURNS ON THE RIGHT SIDE OF THE MOUTH.

  Patient problems: Burn(s)

  MAUDE report 9772706 ↗
• InjuryOct 2, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD BLEEDING AND WENT TO RURAL EMERGENCY DEPARTMENT WHERE THE PATIENT TURNED AWAY AND DID NOT GET LABORATORY. THE PATIENT PRESENTED IN EMERGENCY DEPARTMENT AGAIN AND STILL DID NOT HAVE LABORATORY DONE AND WAS SENT HOME AFTER 4 HOURS OBSERVATION. THE PATIENT CONTINUED TO HAVE INTERMITTENT BLEEDING AT HOME AND WENT TO HOSPITAL THE NEXT DAY. PATIENT'S HEMOGLOBIN WAS LOW AT THAT POINT IT NEEDED A BLOOD TRANSFUSION. SURGEON STATED THAT THERE WAS NOT AN ARTERIAL BLEED BUT IT WAS VENOUS OOZING ALL WEEKEND. PATIENT HAD TO BE TAKEN TO OPERATING ROOM AND CAUTERIZED TO STOP BLEEDING AND HAD TO BE TRANSFUSED BECAUSE OF A LOT OF BLOOD LOSS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9149335 ↗
• InjurySep 19, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THREE DAYS AFTER TONSILLECTOMY, THE DEVICE HAD INADEQUATELY SEALED THE INFERIOR POLE OF LEFT TONSIL BED. REOPERATION WAS INITIATED TO COAGULATE THE TONSIL BED. THE PATIENT HAD 1000 CUBIC CENTIMETERS (CC) OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS SENT HOME STABLE WITH NO ACTIVE BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9090446 ↗

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