Maestro 4000™ Controller M0044000R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729861942), received between Oct 17, 2018 and Dec 4, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (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.

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 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 ↗
• MalfunctionSep 26, 2019Power Conditioning Problem; Therapy Delivered to Incorrect Body Area; Defective Device; Device Displays Incorrect Message; Power Conditioning Problem; Therapy Delivered to Incorrect Body Area; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE GENERATOR STARTED ABLATING SPONTANEOUSLY WITHOUT TRIGGERING ACTION. DURING AN ABLATION PROCEDURE WHILE INSIDE THE PATIENT'S RIGHT ATRIUM (RA), LEFT ATRIUM (LA) AND CORONARY SINUS (CS), THE MAESTRO GENERATOR STARTED ABLATION SPONTANEOUSLY WITHOUT TRIGGERING ACTION ON FOOT PEDAL. PRIOR TO THE INADVERTENT ABLATION, THE PHYSICIAN HAD ATTEMPTED TO INITIATE AN ABLATION BY PRESSING ON THE FOOT PEDAL CONTROLLER WHEN MULTIPLE DIAGNOSTIC MESSAGES SUBSEQUENTLY APPEARED ON BOTH THE GENERATOR AND METRIQ PUMP. ON MULTIPLE OCCASIONS, THE ERRORS D07 (TEMPERATURE TOO HIGH) AND D12 (CHECK PUMP) OCCURRED ON GENERATOR AND P03, P05 AND MANUAL MODE ON THE METRIQ PUMP. DURING AND IMMEDIATELY BEFORE ABLATION. A LOCAL BOSTON SCIENTIFIC REPRESENTATIVE WAS PRESENT AT THE PROCEDURE TO ASSIST WITH MANAGING THE EQUIPMENT AND TROUBLESHOOTING THE DIAGNOSTIC MESSAGES. THE DIAGNOSTIC CONDITION WAS CORRECTED, AND THE BSC REPRESENTATIVE CLEARED THE DIAGNOSTIC MESSAGES FROM THE GENERATOR AND THE METRIQ PUMP IN ORDER TO ALLOW FOR ANOTHER ABLATION TO BE INITIATED. THE TROUBLESHOOTING MEASUREMENTS APPLIED WERE ACCORDING SENIOR FCS GUIDANCE ON THE PHONE AND ACCORDING TO BOTH EQUIPMENT'S 'DIAGNOSTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125198 ↗
• MalfunctionAug 19, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOTSWITCH FAILED TO HALT RADIO FREQUENCY (RF) DELIVERY. DURING AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, ABLATION CONTINUED AFTER THE FOOT PEDAL ON THE MAESTRO 4000 CONTROLLER WAS RELEASED. IT WAS NECESSARY FOR THE PHYSICIAN TO PRESS THE PEDAL AND RELEASE IT AGAIN TO STOP THE ABLATION DELIVERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907917 ↗
• MalfunctionAug 13, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE FOOT PEDAL WAS ACTING "SQUIRRELY." DURING AN ABLATION PROCEDURE, THE FOOT PEDAL WAS ACTING "SQUIRRELY." NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER OR SPECIFIC INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889885 ↗
• MalfunctionJul 30, 2019No Display/Image; Temperature Problem; No Display/Image; Temperature Problem

  IT WAS REPORTED THAT THE UNIT WAS NOT BURNING AT THE DESIRED TEMPERATURE. DURING A PROCEDURE THE MAESTRO 4000 CONTROLLER TEMPERATURE CONTROL LIGHT DID NOT TURN ON WHEN IN TEMPERATURE CONTROL MODE. THE USER NOTED THAT THE UNIT WAS NOT BURNING AT THE DESIRED TEMPERATURE. THE PROCEDURE WAS COMPLETED WITH THE UNIT AND NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843183 ↗
• MalfunctionJul 11, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT FOOTSWITCH FAILED TO HALT ABLATION. DURING A RIGHT ATRIAL FLUTTER PROCEDURE INVOLVING A MAESTRO 4000 CARDIAC ABLATION SYSTEM, THE MAESTRO GENERATOR CONTINUED TO DELIVER RF 5 TO 10 SECONDS AFTER HAVE RELEASED THE FOOTSWITCH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780361 ↗
• MalfunctionJan 17, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT FOOT SWITCH FAILED TO HALT ABLATION. IT WAS REPORTED THAT DURING ABLATION WITH AN MAESTRO 4000 SYSTEM THE FOOTSWITCH "BLOCKS" AND FAILED TO HALT ABLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257996 ↗
• MalfunctionOct 17, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THEY WERE UNABLE TO HALT ABLATION ENERGY DELIVERY. IT WAS REPORTED THAT DURING ENERGY DELIVERY THE MAESTRO 4000 FOOT SWITCH DID NOT COME OFF ABLATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7973930 ↗