Maestro 4000™ Controller M00440000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08714729861911), received between Aug 22, 2018 and Feb 27, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (30 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Communication or Transmission Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THE METRIQ PUMP DISPLAYED THE ERROR MESSAGE "CHECK PUMP", WHILE THE MAESTRO SYSTEM DISPLAYED THE ERROR MESSAGES "BUBBLE DETECTED", "CHECK STANDBY FLOW", AND "SYSTEM FAULT". CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. A MAESTRO 4000 CONTROLLER AND A METRIQ PUMP WERE SELECTED FOR USE. DURING PREPARATION, AFTER THE PATIENT WAS SEDATED, THE METRIQ PUMP DISPLAYED THE ERROR MESSAGE "CHECK PUMP". AT THE SAME TIME, THE MAESTRO DISPLAYED THE ERROR MESSAGES "BUBBLE DETECTED", "CHECK STANDBY FLOW", AND "SYSTEM FAULT". CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOTH DEVICES ARE EXPECTED TO BE RETURNED FOR ANALYSIS. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST-SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475231 ↗
• MalfunctionNov 5, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE POD COULD NOT RECOGNIZE THE CATHETER AND DISPLAYED AN ERROR. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED POST SEDATION. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST SEDATION. DURING AN ELECTROPHYSIOLOGY PROCEDURE, A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE UNIT SUDDENLY STOPPED FUNCTIONING AND WAS UNABLE TO RECOGNIZE THE ABLATION CATHETER, DESPITE THE CATHETER BEING VISIBLE ON THE RHYTHMIA SYSTEM. THE SYSTEM DISPLAYED A FINDING CATHETER MESSAGE. THE ISSUE WAS UNABLE TO BE RESOLVED, AND THE PROCEDURE WAS CANCELED. THE PATIENT WAS UNDER CONSCIOUS SEDATION DURING THE TIME OF CANCELLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476650 ↗
• MalfunctionSep 17, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT POOR TEMPERATURE CONTROL WAS OBSERVED. DURING A RADIO FREQUENCY (RF) ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (A FIB) AND AN ATRIAL FLUTTER, A MAESTRO 4000 GENERATOR WAS SELECTED FOR USE. ACCOUNT WAS PERFORMING RF CAVOTRICUSPID ISTHMUS (CTI) LINE POST FARAVIEW CASE WITH 10MM BLAZER CATHETER. BIDIRECTIONAL BLOCK WAS ACHIEVED, HOWEVER, DURING RF DELIVERY, IMPEDANCES WERE OBSERVED TO BE IN THE HIGH 60S TO LOW 80S, WHICH APPEARED SLIGHTLY LOW. MAESTRO SETTINGS WERE 100W, 60C, AND 120 SECONDS. THE CONTROLLER WAS IN TEMPERATURE CONTROL MODE. TEMPERATURES VARIED THROUGHOUT THE PROCEDURE. AT ONE POINT, A TEMPERATURE OF 65C WITH APPROXIMATELY 20 WATTS TRIGGERED A TEMPERATURE WARNING, CAUSING THE WATTAGE TO DROP TO ZERO. PRODUCT SUPPORT SUSPECTED THAT, SINCE TARGET TEMPERATURES WERE BEING REACHED AT TIMES WITH RELATIVELY LOW POWER, THE CONTROLLER WAS CONTINUOUSLY ATTEMPTING TO TITRATE POWER AND RECOMMENDED USING A LOWER MAXIMUM POWER SETTING AND MANUALLY TITRATING UP IF NEEDED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS. EQUIPMENT IS NOT EXPECTED TO BE RETURNED. ON THE ONE INCIDENCE THE TEMPERATURE WAS HIGH AND DR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077000 ↗
• MalfunctionApr 3, 2025Connection Problem; Connection Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PROCEDURE, A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. FOLLOWING THE RADIOFREQUENCY DELIVERY OF SOME POINTS, THE MAESTRO 4000 RF GENERATOR SUDDENLY STOPPED WORKING, NO LONGER RECOGNIZING THE ABLATOR CATHETER DESPITE THE FACT THAT ON THE RHYTHMIA SYSTEM THE CATHETER WAS SHOWING. THE ERROR SHOWN ON THE MAESTRO IS "FINDING CATHETER....". THE CATHETER CONNECTION CABLES AND THE ABLATION CATHETER WERE REPLACED, HOWEVER THE ISSUE PERSISTED. THE SYSTEMS WERE RESTARTED BUT THE PROBLEM COULD NOT BE RESOLVED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS ALSO NOTED THAT THE RECOGNITION ISSUE OCCURRED AT INITIAL CONNECTION. AS THE ISSUE OCCURRED DURING USE, IT WAS ABLE TO TRACK THE LOCATION OF THE CATHETER ON OPAL MAPPING SYSTEM AND SEE CARDIAC DATA ON SCREEN. THE CATHETER WAS ABLE TO BE PHYSICALLY CONNECTED SUCCESSFULLY. THERE WERE NO NOISY ELECTRODES. THERE WERE NO RECENT CHANGES IN LAB SETUP. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA AT THE TIME OF THE PROCEDURE CANCELLATION. EQUIPMENT REPLACEMENT WAS REQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766745 ↗
• MalfunctionMar 5, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. WHEN THE INTELLANAV MIFI OI CATHETER WAS IN THE LUMEN OF THE LEFT ATRIUM, SPONTANEOUS ABLATION OCCURRED. THE EPISODE LASTED 10 SECONDS BUT WAS NOT ACCOMPANIED BY ANY ADVERSE EFFECTS ON THE PATIENT. DURING THE INCIDENT, THE MEDICAL STAFF WAS ABLE TO VERIFY THAT THERE WAS NO SPONTANEOUS PRESSING OF THE PEDAL AND THE GENERATOR BUTTONS. THE INCIDENT ENDED AFTER THE CATHETER AND CABLE WERE DISCONNECTED. THEN, AFTER RECONNECTING THE CATHETER AND CABLE, THE PROCEDURE WAS CONTINUED. THE CASE DID NOT REPEAT ITSELF OVER TIME. THE OPERATION WAS SUCCESSFUL WITHOUT HARM TO THE PATIENT. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528877 ↗
• MalfunctionNov 26, 2024Output below Specifications; Temperature Problem; Output below Specifications; Temperature Problem

  IT WAS REPORTED THAT MAESTRO 4000 DOES NOT ADEQUATELY REGULATE TEMPERATURE. DURING AN ABLATION PROCEDURE, A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. IT WAS OBSERVED THAT MAESTRO 4000 DOES NOT ADEQUATELY REGULATE TEMPERATURE AND SHOWS A DECREASE IN POWER WHEN INITIATING ABLATION DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE IS EXPECTED TO BE RETURN FOR ANALYSIS, ONSITE REPAIR IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783016 ↗
• MalfunctionSep 3, 2024Use of Device Problem; Device Displays Incorrect Message; Use of Device Problem; Device Displays Incorrect Message

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT THE ERROR MESSAGE D06 TEMP OUT OF RANGE OCCURRED ON THE MAESTRO 4000. WHEN THE ISSUE OCCURRED, A PATIENT WAS ON THE TABLE. THEY WERE UNABLE TO CLEAR THE ERROR AND THE PROCEDURE WAS CANCELLED AT THAT TIME. IT IS CURRENTLY UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127312 ↗
• MalfunctionMay 2, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MAESTRO 4000 GENERATOR FAILED TO DELIVER ENOUGH ABLATION POWER WHEN TEMPERATURE CONTROL SETTING WAS SELECTED. THE OPERATOR REPLACED THE GENERATOR WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233549 ↗
• MalfunctionMay 2, 2024Output below Specifications; Output below Specifications

  THE MAESTRO 4000 GENERATOR WAS SELECTED FOR USE DURING THE PROCEDURE OF ATRIOVENTRICULAR NODE ABLATION. IT WAS REPORTED THAT WHEN TEMPERATURE CONTROL SETTING WAS SELECTED THE GENERATOR FAILED TO DELIVER ENOUGH ABLATION POWER. THE TEMPERATURE SPIKED. THE OPERATOR REPLACED THE GENERATOR WITH A NON-BOSTON SCIENTIFIC DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED. THE GENERATOR IS EXPECTED TO RETURN. IT WAS FURTHER REPORTED THAT NO ERROR MESSAGES DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233258 ↗
• MalfunctionNov 3, 2023Device Displays Incorrect Message; Temperature Problem; Device Displays Incorrect Message; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE GENERATOR TEMPERATURE COULD NOT INCREASE ABOVE 28 DEGREES CELSIUS AND THE ERROR MESSAGE M02 POWER LIMITED, POWER SETTING WAS DISPLAYED. THE GENERATOR POWER COULD NOT BE INCREASED ABOVE 50W. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065417 ↗
• MalfunctionOct 2, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE WITH TEMPERATURE CONTROL DURING PROCEDURE, THIS REMAINED AT 27 DEGREES, COOLED AND UNCOOLED DURING ABLATION AND DOES NOT INCREASE. NO PATIENT COMPLICATIONS WERE REPORTED, AND NO ERROR MESSAGES OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852113 ↗
• MalfunctionApr 25, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE GENERATOR CONTROLLER EXHIBITED LOW POWER. DURING A PROCEDURE A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. THE GENERATOR UNIT WAS NOT GETTING TO MAX TEMPERATURE AND WAS STAYING AT LOW POWER. MULTIPLE CATHETERS WERE ATTEMPTED TO BE USED WITH THE EQUIPMENT, BUT THE ISSUE REMAINED. THE CONTROLLER WAS REPLACED WITH A DIFFERENT MODEL DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE CONTROLLER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY WHERE IT IS AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808518 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RHYTHMIA NAVIGATION AND ABLATION PROCEDURE WAS PERFORMED ON (B)(6) 2022 WITH A MAESTRO ABLATION GENERATOR FOR CAVOTRICUSPID ISTHMUS (CTI) ABLATION. THE MAPPING AND ABLATION PROCEDURE WAS PERFORMED WITHOUT ISSUE. DURING A ROUTINE FOLLOW UP THE PATIENT SHOWED A NEARLY HEALED 2X2 CM LOWER BACK WOUND AT THE TYPICAL LOCATION OF THE INDIFFERENT ADHESIVE PAD. THE HEALTH FACILITY USED TWO NON-BOSTON SCIENTIFIC INDIFFERENT GROUNDING PADS FOR THE PROCEDURES TO DISPERSE ENERGY. NO OTHER WOUNDS WERE PRESENT. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Burn(s)

  MAUDE report 16184079 ↗
• MalfunctionJan 4, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING AN ABLATION TO TREAT SUPRAVENTRICULAR TACHYCARDIA (SVT), THERE WAS NOISE ON THE RADIOFREQUENCY CHANNELS FROM THE MAESTRO 4000. THE NOISE WAS CONSISTENT, HIGH FREQUENCY, OBSERVED FROM THE START OF THE CASE ON THE RECORDING SYSTEM. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE, BUT THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096512 ↗
• MalfunctionMay 4, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  DURING PREPARATION, A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. IT WAS REPORTED THAT MAESTRO SYSTEM FAILED AFTER SELF TEST. THE SOFTWARE WAS RELOADED SEVERAL TIMES, HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED AND WAS NOT COMPLETED. IT IS UNKNOWN WHETHER THE PATIENT WAS SEDATED AT TIME OF PROCEDURE CANCELLATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280228 ↗
• MalfunctionNov 4, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE MAESTRO 4000 GENERATOR OUTPUT WAS FLUCTUATING, USUALLY OUTPUT IS ON THE WEAK SIDE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752529 ↗
• MalfunctionJul 16, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE MAESTRO 4000 GENERATOR OUTPUT WAS FLUCTUATING, USUALLY OUTPUT IS ON THE WEAK SIDE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT SEVERAL PATIENTS HAVE COME BACK FOR REPEAT PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180868 ↗
• MalfunctionMay 26, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE MAESTRO 4000 GENERATOR OUTPUT WAS FLUCTUATING, USUALLY OUTPUT IS ON THE WEAK SIDE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882716 ↗
• MalfunctionJan 26, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERS AND A MAESTRO CONNECTION BOX WERE USED IN A ATRIAL FIBRILLATION ABLATION PROCEDURE. INTELLANAV MIFI OI WAS CONNECTED RECOGNIZED BY MAESTRO GENERATOR, NORMAL IMPEDANCE WAS LISTED (123 OHMS) TEMPERATURE OF CATHETER WAS LOW AROUND 25 DEGREES CELSIUS. WHEN STARTING THE FIRST ABLATION WITH A POWER OF 30 WATTS AND FLOW OF 30ML THE TEMPERATURE DROPPED BELOW 15 DEGREES CELSIUS, AND A D06 TEMP OUT OF RANGE ERROR WAS DISPLAYED. THIS ERROR STOPPED THE ABLATION. ALL CONNECTIONS WERE CHECKED AND NO ISSUES WERE IDENTIFIED. A SECOND ABLATION WAS ATTEMPTED AND THE SAME D06 ERROR OCCURRED. THE OUTPUT WAS LOWERED TO 25 WATTS WITH IRRIGATION OF 17ML, TEMPERATURE STAYED ABOVE 15 DEGREES. THE ABLATION CATHETER, CONNECTION CABLES, AND MAESTRO POD WERE SWAPPED WITHOUT SOLVING THE PROBLEM. WITH A FLOW OF 10ML AND POWER OF 30 WATTS MORE ABLATIONS WERE ATTEMPTED BUT IT IS NOT SURE IF THESE WERE EFFECTIVE. TEMPERATURE WITH THESE SETTINGS WAS AROUND 18 DEGREES CELSIUS. ISOLATION OF INFERIOR PART OF LEFT PULMONARY VALVES WERE ATTEMPTED AND AN ANTERIOR AND POSTERIOR LINE WAS DONE. THE PROCEDURE WAS CANCELED DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11229676 ↗
• MalfunctionJan 12, 2021Data Problem; Data Problem

  IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER WAS USED IN A ABLATION PROCEDURE. HOWEVER IT WAS NOTED THAT THE UNIT IS NOT ABLATING WHEN THE FOOT PEDAL IS ENGAGED. IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE CULPRIT DEVICE WAS A MAESTRO 4000 POD NOT THE CONTROLLER.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11156314 ↗
• MalfunctionDec 21, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER WAS USED IN A HIS ABLATION PROCEDURE. AT THE START OF ARRHYTHMIA ABLATION, WHEN THE PHYSICIAN TRIES TO CONNECT ALL DEVICES AND THE MAESTRO 4000 DOES NOT ALLOW TO CONFIGURE THE ENERGY AND WAS DISPLAYING SYSTEM ERROR. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS CANCELED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11050298 ↗
• MalfunctionDec 18, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT FAILURE TO HALT ABLATION OCCURRED. A MAESTRO 4000 CONTROLLER WAS SELECTED FOR A ABLATION PROCEDURE. DURING THE ABLATION IT WAS NOTICED THAT THE RADIOFREQUENCY ENERGY (RF) CONTINUED AFTER THE FOOT-PEDAL WAS RELEASED. THE ISSUE WAS CORRECTED BY PRESSING THE FOOTSWITCH AGAIN. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490585 ↗
• MalfunctionNov 19, 2019Device Remains Activated; Device Remains Activated

  THE RADIO FREQUENCY(RF) ENERGY WAS NOT HALTED. A MAESTRO 4000 CONTROLLER WAS SELECTED FOR A SUPRAVENTRICULAR TACHYCARDIA(SVT) ABLATION PROCEDURE. HOWEVER DURING THE ABLATION PROCEDURES OF SVT THE RF WAS NOT INTERRUPTED BY USING THE PEDAL OF MAESTRO 4000. RF WAS STOPPED BY PRESSING THE BUTTON ON THE GENERATOR. NO PATIENT COMPLICATIONS OCCURRED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341800 ↗
• MalfunctionOct 23, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOT SWITCH OF THE MAESTRO 4000 CONTROLLER FAILED TO HALT RADIOFREQUENCY (RF) DELIVERY. DURING AN ABLATION PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA (SVT), THE FOOT PEDAL DID NOT TERMINATE ABLATION DELIVERY AFTER IT WAS RELEASED. ACCORDING TO THE PHYSICIAN, HE WAS PERFORMING A SECOND RF BURN TO THE SLOW PATHWAY OF THE ATRIOVENTRICULAR (AV) NODE. WHEN HE WAS FINISHED ABLATING, HE TOOK HIS FOOT OFF THE PEDAL ONLY TO FIND THAT THE GENERATOR CONTINUED TO DELIVER RF. THE PHYSICIAN QUICKLY WITHDREW THE CATHETER AWAY FROM THE ABLATION SITE AND A FEW SECONDS LATER THE GENERATOR STOPPED DELIVERING RF SPONTANEOUSLY. THE PROCEDURE WAS COMPLETED AND NO COMPLICATIONS OCCURRED AS A RESULT OF THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224112 ↗
• MalfunctionOct 22, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOT PEDAL OF THE MAESTRO 4000 CONTROLLER FAILED TO HALT RADIOFREQUENCY (RF) DELIVERY. DURING AN ABLATION PROCEDURE, THE MAESTRO FOOT PEDAL WOULD GET "STUCK" AT RANDOM TIMES THROUGHOUT THE CASE. PATIENT ADVERSE EVENTS WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220055 ↗