Bovie AA01Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00607151011017), received between Jun 6, 2019 and Jun 18, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Unexpected Shutdown

  COMPLAINANT ALLEGES "DOES NOT LAST LONG, WE HAVE TO USE 2 PER SURGERY. WE FEAR THAT SHORTLY, THEY WILL STOP WORKING BEFORE THEY ARE EVEN USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549835 ↗
• MalfunctionFeb 19, 2026Intermittent Loss of Power

  COMPLAINANT ALLEGES "THE PHYSICIAN WAS PERFORMING A PROCEDURE TO IMPLANT A VASCULAR GRAFT. DURING THE GRAFT PREPARATION USING THE SUBJECT DEVICE (AA01), THE HEATING FUNCTION AT THE DISTAL TIP GRADUALLY WEAKENED, MAKING IT IMPOSSIBLE TO CONTINUE THE GRAFT SHAPING OPERATION. THE USER REPLACED THE DEVICE WITH ANOTHER UNIT OF THE SAME MODEL AND CONTINUED THE PROCEDURE WITHOUT FURTHER ISSUES. THERE WAS NO HARM TO THE PATIENT, AND NO PROCEDURAL DELAY WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390469 ↗
• MalfunctionDec 16, 2025Break; Break

  COMPLAINANT ALLEGES "THE DEVICE WAS USED DURING THORACIC VASCULAR REPLACEMENT SURGERY FOR THE PURPOSE OF CREATING A HOLE IN THE ARTIFICIAL GRAFT. DUE TO A BREAKAGE IN THE LEAD WIRE AT THE TIP, ELECTRICAL CONDUCTION DID NOT OCCUR. THE PRODUCT WAS REPLACED WITH A SECOND UNIT OF THE SAME MODEL FROM A DIFFERENT LOT; HOWEVER, THE SAME ISSUE OCCURRED WITH THE SECOND UNIT. NO ALTERNATIVE PRODUCT WAS USED, AND THE PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820922 ↗
• MalfunctionNov 13, 2025Melted; Melted

  COMPLAINANT ALLEGES "THE CAUTERY WAS SELECTED FOR USE TO PUNCH A HOLE TO A PROSTHETIC VESSEL GRAFT. THE FIRST PRODUCT BECAME TOO HOT, SO THE TIP OF THE CAUTERY MELTED. THE CAUTERY WAS REPLACED WITH THE SAME LOT#'S ONE. THE TIP OF THE SECOND PRODUCT WAS FOUND TO HAVE BEEN BROKEN FROM THE BEGINNING. THE 3RD CAUTERY WAS USED TO PROCEED THE PROCEDURE. NO ADVERSE HEALTH CONSEQUENCE TO THE PATIENT WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547922 ↗
• MalfunctionJun 12, 2025Overheating of Device; Overheating of Device

  COMPLAINANT ALLEGES: "PATIENT WAS UNDERGOING OFFICE VASECTOMY. HANDHELD CAUTERY WAS BEING USED. I NOTED THAT THE CAUTERY SEEMED TO BE PRODUCING MORE HEAT AND SMOKE THAN USUAL, AND I NOTED WARMTH ON MY HAND WHILE USING IT. IT ALSO BURNED 2 MARKS ON THE DRAPE ON THE BACK TABLE WHEN IT WAS SET DOWN, DESPITE THE TIP NOT BEING IN DIRECT CONTACT WITH THE DRAPE. SUBSEQUENTLY, A RAYTEC THAT WAS NOT IN DIRECT CONTACT WITH THE CAUTERY (AT LEAST 3 INCHES AWAY) APPEARED TO HAVE SOME BROWN COLOR CHANGES SO I PICKED IT UP OFF THE PATIENT TO EXAMINE IT. IT BEGAN TO SMOKE. WHILE WALKING OVER TO THE SINK WITH RAYTEC IN HAND, THE RAYTEC CAUGHT ON FIRE. I DROPPED IT IN THE SINK AND THE FIRE WAS PUT OUT WITH WATER."

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22194409 ↗
• MalfunctionAug 15, 2024Break; Break

  THE COMPLAINANT ALLEGES, "OUR UROLOGY PRACTICE HAS HAD 3 BREAK FROM THIS LOT# DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997643 ↗
• MalfunctionAug 15, 2024Break; Break

  THE COMPLAINANT ALLEGES, "OUR UROLOGY PRACTICE HAS HAD 3 BREAK FROM THIS LOT# DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997625 ↗
• MalfunctionAug 15, 2024Break; Break

  THE COMPLAINANT ALLEGES, "OUR UROLOGY PRACTICE HAS HAD 3 BREAK FROM THIS LOT# DURING PROCEDURES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997614 ↗
• MalfunctionAug 2, 2024Fire; Fire

  RECEIVED VIA FDA'S MEDSUN PROGRAM (REPORT NUMBER: (B)(4)). THE COMPLAINANT ALLEGES, "DURING A PEDIATRIC SURGERY, THE PATIENT WAS MASKED DOWN FOR A LYSIS OF PENILE ADHESION. WHEN THE SURGEON USED THE CAUTERY HIGH TEMP FINE TIP BOVIE IT TOOK A MINUTE TO ACTIVATE AND HEAT UP. ONCE IT WARMED UP ENOUGH, THE SURGEON STARTED THE PROCEDURE. THE FIRST ASSIST STUDENT NOTICED THE RAYTEC SPONGE IN THEIR HAND STARTED TURNING BLACK AND FELT WARM. THEY PLACED THE RAYTEC ON THE MAYO STAND AND AN EMBER FORMED AND CAUGHT ON FIRE. THE SURGICAL TECH TOSSED THE RAYTEC ON THE FLOOR TO AVOID FURTHER SPREAD. THE FIRE WAS THEM PUT OUT SAFELY WITH NO HARM TO THE PATIENT OR OTHERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892540 ↗
• MalfunctionJun 13, 2024Break; Break

  THE COMPLAINANT ALLEGES, "BOVIE WAS USED ON A PT'S FINGER NAIL TODAY. TWO OF THEM BREAK MID PROCEDURE. THEY A BOTH THE SAME LOT NUMBER".

  Patient problems: Insufficient Information

  MAUDE report 19533430 ↗
• MalfunctionMay 24, 2024Break; Break

  THE COMPLAINANT ALLEGED, "THE TIP BROKE OFF DURING USE. NO PATIENT CONSEQUENCE, HOWEVER IT WAS NOTED THAT THE SURGERY WAS CANCELED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393538 ↗
• MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem

  THE COMPLAINANT ALLEGES, "WE HAD A BATTERY BOVIE THAT MALFUNCTIONED. THE BUTTON STUCK AND PROCEEDED TO BURN THROUGH A DRAPE AFTER IT WAS TURNED OFF. THERE WAS NO PATIENT INJURY ."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862972 ↗
• MalfunctionJan 2, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER ALLEGED THAT DURING A CARDIOVASCULAR PROCEDURE THE TIP OF THE CAUTERY BROKE OFF. THE SURGEON STATED THAT THERE WAS NO EXTERNAL FORCE APPLIED TO THE TIP. ON 12/20/2023 ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THAT THE TIP OF THE CAUTERY DID NOT DETACH FROM THE DEVICE. IT WAS CONFIRMED TO BE DEFORMED COMPARED TO THE ORIGINAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432129 ↗
• MalfunctionMay 23, 2023Temperature Problem; Temperature Problem

  THE CUSTOMER ALLEGED THAT WHILE THEY WERE CAUTERIZING THE EYELID, THE CAUTERY SPARKED AND CAUSED A BURN TO EYELID AND BURNED THE PATIENT'S LASHES. THE PATIENT RECEIVED A MINOR BURN WITH NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16988861 ↗
• MalfunctionMay 23, 2023Temperature Problem; Temperature Problem

  THE CUSTOMER ALLEGED THAT THE CAUTERIES ARE GETTING HOT AND SPARKING WHEN IN USE.

  Patient problems: Insufficient Information

  MAUDE report 16988860 ↗
• MalfunctionAug 26, 2022Fire; Fire

  THE CUSTOMER ALLEGED THAT WHILE USING THE BOVIE IT APPEARED TO SET FIRE TO A PIECE OF GAUZE. THE GAUZE WAS SPARKED AND CAUSED A FLAME TO BURN OFF SOME OF THE PATIENT'S EYEBROW. THERE WAS NO ADDITIONAL EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307175 ↗
• MalfunctionJun 15, 2022Fire

  CUSTOMER ALLEGES THAT AA01 HAS IGNITED DURING USE WHEN CAUTERIZING "FOLDS" WHICH THEN CAUGHT ON FIRE CAUSING DANGER TO STAFF AND PATIENT. PATIENT RECEIVED MINOR BURNS TO FACE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14700414 ↗
• MalfunctionFeb 15, 2022Fire

  THE CUSTOMER ALLEGED THAT DURING A RODENT SURGERY THE HIGH TEMP CAUTERY SPARKED AND CAUSED A FIRE. THERE WAS NO LAB PERSONNEL INJURED IN THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538466 ↗
• MalfunctionDec 22, 2021Improper or Incorrect Procedure or Method

  THE REPORTER INITIALLY SENT AN EMAIL REQUESTING THAT SOMEONE CONTACT THEM REGARDING "AN ADVERSE EVENT THAT OCCURRED WHILE USING THE BOVIE CAUTERY FINE TIP REF (B)(4)." NO OTHER DETAILS REGARDING THE EVENT WERE RECEIVED. AFTER REPEATED ATTEMPTS TO FOLLOW UP FOR ADDITIONAL INFORMATION, THE REPORTER RESPONDED ON STATING: "PLEASE DISREGARD. I DO BELIEVE THIS WAS ALL RELATED TO USER ERROR."

  Patient problems: Insufficient Information

  MAUDE report 13062696 ↗
• MalfunctionSep 9, 2020Sparking

  THE FACILITY RECEIVED TWO ACCOUNTS OF THE CAUTERY PENS FORMING A SPARK DURING A CASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10512192 ↗
• MalfunctionJul 21, 2020Self-Activation or Keying; Failure to Shut Off

  THE CUSTOMER WAS PREPARING THE DEVICE WHEN THE CAUTERY BECAME ACTIVE WITHOUT TOUCHING THE BUTTONS. THE CAUTERY WOULD NOT TURN OFF AND THE BATTERIES HAD TO BE REMOVED. THERE WAS NO HARM TO THE PATIENT OR THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302480 ↗
• MalfunctionJun 14, 2019Fire

  DURING A PROCEDURE THE FENESTRATED DRAPE,A PIECE OF STERILE GAUZE AND THE DOCTOR'S GLOVE CAUGHT FIRE. IT WAS DISCOVERED LATER BY NOTIFICATION FROM PARENTS THAT THE CHILD ALSO RECEIVED A SMALL BURN ON THE LEG THAT WAS NOT NOTICED AT THE TIME OF THE PROCEDURE.

  Patient problems: Burn, Thermal

  MAUDE report 8700586 ↗
• MalfunctionJun 6, 2019Fire

  THE CUSTOMER ALLEGED THAT DURING A SURGERY MEANT TO REMOVE A CONJUNCTIVAL PAPILLAE INJURY, THE CAUTERY USED TO COAGULATE THE SMALL VEIN BECAME HOT IN THE TIP. WHEN IT CAME CLOSE TO THE AREA THAT WAS BEING TREATED, A FLAME OCCURRED THAT BURNED THE PATIENT'S EYELASHES AND SURROUNDING AREAS WITH SUBSEQUENT SCALDING.

  Patient problems: Burn, Thermal

  MAUDE report 8675994 ↗