VULCAN 7210812SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010542182), received between Jan 8, 2018 and May 29, 2021 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD VOLTAGE CALIBRATION FAIL. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905738 ↗
• MalfunctionMay 29, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VOLTAGE CALIBRATION OF THE VULCAN GENERATOR FAILED. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905737 ↗
• MalfunctionApr 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD THE POWER SUPPLY BROKE DOWN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735999 ↗
• MalfunctionApr 14, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING INSPECTION, THE POWER OF THE "VULCAN GENERATOR" TURNED OFF DURING OUTPUT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665848 ↗
• MalfunctionApr 6, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A "VOLTAGE CALIBRATION" FAILURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617299 ↗
• MalfunctionMar 27, 2021Calibration Problem; Communication or Transmission Problem; Protective Measures Problem; Calibration Problem; Communication or Transmission Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE SET TEMP BUTTON AND COAG BUTTON WERE FLASHING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A VOLTAGE CAL FAILURE WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579351 ↗
• MalfunctionFeb 9, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS REBOOTING DURING OPERATION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305269 ↗
• MalfunctionJan 18, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR SHOWED A VOLTAGE CAL FAILURE MESSAGE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184030 ↗
• MalfunctionDec 28, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR POWERED OFF. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085154 ↗
• MalfunctionDec 28, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR POWERED OFF. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085101 ↗
• MalfunctionDec 15, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR POWERED OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009212 ↗
• MalfunctionDec 11, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR DOES NOT POWER ON. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992573 ↗
• MalfunctionDec 9, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR POWER OFF. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975192 ↗
• MalfunctionNov 19, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A "CURRENT CALIBRATION FAILURE". NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10871888 ↗
• MalfunctionNov 18, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A VOLTAGE CAL FAILURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10862975 ↗
• MalfunctionNov 12, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR DISPLAYED A POWER CAL FAILURE. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10828039 ↗
• MalfunctionNov 12, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE GENERATOR SUDDENLY HAD THE POWER DOWN. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10828016 ↗
• MalfunctionOct 26, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, THE "VULCAN GENERATOR" POWER OFF WHEN WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10737757 ↗
• MalfunctionOct 22, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN HAD THE POWER DOWN. NO CASE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10718246 ↗
• MalfunctionOct 1, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A POWER CAL FAILURE ERROR. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10618258 ↗
• MalfunctionSep 18, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD NO POWER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10554208 ↗
• MalfunctionSep 16, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THE VULCAN GENERATOR HAD NO OUTPUT POWER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10543717 ↗
• MalfunctionSep 16, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A POWE DROPS. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10543382 ↗
• MalfunctionAug 31, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR DID NOT RECOGNIZE THE RETURN ELECTRODE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10474199 ↗
• MalfunctionAug 12, 2020Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE GENERATOR HAD A POWER SUPPLY FAILURE, THE POWER WAS DOWN. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10398667 ↗