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Bovie AA05Recalls & reported problems

Aspen Surgical Products, Inc. · CAUTERY HIGH TEMPERATURE 2'' EXTENDED SHAFT LOOP TIP · Class 2

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00607151011055), received between Jul 28, 2022 and Apr 22, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 2 reportsMar 2026: 2 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Power Up4
  • Activation Failure1
  • Battery Problem1
  • Break1
  • Complete Loss of Power1
  • Device Remains Activated1
  • Difficult or Delayed Activation1
  • Energy Output Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 22, 2026Failure to Power Up

    COMPLAINANT ALLEGES "DURING THE SURGERY ON MARCH 24, THE CAUTERY WAS OPENED AND FOUND WITH THE CAP DETACHED. WHEN THE SWITCH WAS PRESSED, THE DEVICE DID NOT RESPOND AT ALL. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT WAS REPORTED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24957024 ↗
  • MalfunctionApr 3, 2026Failure to Power Up

    COMPLAINANT ALLEGES "TO BEGIN CAUTERIZATION, IT IS NECESSARY TO PRESS THE GREEN BUTTON AFTER OPENING THE LID. HOWEVER, IN THIS CASE, THE BUTTON WAS ALREADY RECESSED FROM THE BEGINNING, MAKING IT IMPOSSIBLE TO INITIATE THE CAUTERIZATION. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT OCCURRED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24777415 ↗
  • MalfunctionMar 30, 2026Insufficient Heating

    COMPLAINANT ALLEGES "THE ARTIFICIAL BLOOD VESSEL COULD NOT BE SEVERED DUE TO INSUFFICIENT THERMAL CONDUCTIVITY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24714233 ↗
  • MalfunctionMar 24, 2026Failure to Power Up

    COMPLAINANT ALLEGES "THE CAUTERY DID NOT POWER ON WHEN ACTIVATED. THIS OCCURRED DURING HEART SURGERY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24675696 ↗
  • MalfunctionFeb 25, 2026Failure to Power Up

    COMPLAINANT ALLEGES "THE CAUTERY FAILED TO POWER ON WHEN THE USER ATTEMPTED TO SWITCH IT ON. THIS OCCURRED DURING CARDIAC SURGERY. NO DELAY OR PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24445580 ↗
  • MalfunctionFeb 4, 2026Complete Loss of Power

    COMPLAINANT ALLEGES "WE WOULD LIKE TO INFORM YOU OF A NON-COMPLIANCE ISSUE ENCOUNTERED ON (B)(6) 2025, FOR ONE OF OUR CUSTOMERS CONCERNING ONE OF YOUR PRODUCTS. THE REPORTED ANOMALY IS AS FOLLOWS: THERMOCUTTER MALFUNCTION OBSERVED ON THREE DEVICES USED SUCCESSIVELY FROM THE SAME BATCH."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24260814 ↗
  • MalfunctionJan 8, 2026Device Remains Activated

    COMPLAINANT ALLEGES "THE CAUTERIZER REMAINED ACTIVE, AND FURTHER INVESTIGATION REVEALED A LEAKING BATTERY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24011968 ↗
  • MalfunctionAug 12, 2025Activation Failure; Activation Failure

    COMPLAINANT ALLEGES "ACTIVATION BUTTON COLLAPSED INTO DEVICE WHEN ATTEMPTED TO USE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22787622 ↗
  • MalfunctionJun 17, 2025Break; Break

    COMPLAINANT ALLEGES "DURING A CARDIOVASCULAR SURGERY ON (B)(6) 2025, WHILE USING A DISPOSABLE CAUTERY DEVICE, AA05 (#0923Z), THE TUBE PROTECTING THE METAL PART SLIPPED OFF ON ITS OWN AND TOUCHED THE ELECTRIFIED PART, CAUSING IT TO BURN. SINCE THE TUBE IS NOT SUPPOSED TO MOVE, THE DOCTOR JUDGED IT TO BE DEFECTIVE AND STOPPED USING IT IMMEDIATELY. AN ANOTHER AA05 (#0923Z) WAS USED INSTEAD, AND IT WAS WORKED WITHOUT ANY ISSUES."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22236007 ↗
  • MalfunctionJul 28, 2022Energy Output Problem; Difficult or Delayed Activation; Battery Problem; Difficult or Delayed Activation

    THE CUSTOMER ALLEGED THAT THE CAUTERY WAS BEING USED IN BENTALL PROCEDURES TO SOW THE CORONARY "BUTTON" TO THE AORTIC GRAFT. THE FIRST EYE CUATERY THE ROOM STAFF OPENED WAS NOT OPERATING WELL, IT APPEARED AS IF YOU TURNED ON A FLASHLIGHT AND WATCHED IT DIM AS THE BATTERY SLOWLY DIED. THE SECOND ONE THAT WAS OPENED WORKED FOR THE SURGEON BRIEFLY, THEN ALSO STARTED ACTING AS IF THE BATTERY WAS DYING. STAFF OPENED A THIRD, WHICH ACTED VERY SIMILARLY TO THE FIRST AND SECOND, THEREFORE IT WAS NOT USED. THE SURGEON ENDED UP HAVING TO USE AN ALTERNATE MEANS TO CREATE AN OPENING IN THE TUBE GRAFT FOR THE CORONARY BUTTONS, WHICH WAS NOT IDEAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15123086 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.