Maestro 4000 ControllerRecalls & reported problems across all models

We found 3 models of Maestro 4000 Controller by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2018 and Feb 27, 2026 — classified as 1 injury, 67 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (37 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 Maestro 4000 Controller problems

Maestro 4000 Controller models

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

• Maestro 4000™ Controller M00440000

  Cardiac ablation percutaneous catheter
  55 reports
• Maestro 4000™ Controller M0044000R0

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  10 reports
• Maestro 4000™ Controller M0044000H0

  Cardiac ablation percutaneous catheter
  3 reports

Recent Maestro 4000 Controller adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 4, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE DELIVERED ONLY HALF OF ITS EXPECTED POWER OUTPUT. A MAESTRO 4000 CONTROLLER WAS SELECTED FOR USE. IT WAS NOTED THAT THE DEVICE DELIVERED ONLY HALF OF ITS EXPECTED POWER OUTPUT, WITH NO REPORTED ERROR CODES. THERE WERE NO KNOWN PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715817 ↗
• 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 ↗
• MalfunctionOct 14, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE MAESTRO 4000 HAD TEMPERATURE ISSUE. WHEN THE RADIOFREQUENCY IS TURNED UP ON THE CONSOLE THE TEMPERATURE READING GOES DOWN. A DEVICE REPLACEMENT WAS REQUESTED. NO PATIENT COMPLICATION WAS REPORTED. THE EVENT OUTCOME IS UNKNOWN. DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446179 ↗
• 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 ↗
• MalfunctionSep 7, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A MAESTRO 4000 CONTROLLER PRESENTED AN ISSUE. THE DEVICE IS NOT POWERING UP TO THE DESIRED TEMPERATURE. NO PATIENT INVOLVEMENT WAS REPORTED. THE WAS NO INDICATION IF THE DEVICE WILL BE RETURNED FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698786 ↗
• 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 ↗

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