Maestro 3000™ M00421000TCR0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729811923), received between Feb 28, 2017 and Oct 29, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE FOOT PEDAL WAS UNRESPONSIVE. DURING AN ABLATION PROCEDURE, AN ISSUE OCCURRED WITH THE MAESTRO CONSOLE WHERE THE FOOT PEDAL BECAME UNRESPONSIVE AND WOULD NOT REACT ANYMORE. NO PATIENT ISSUES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250072 ↗
• MalfunctionOct 16, 2019Mechanical Problem; Therapy Delivered to Incorrect Body Area; Mechanical Problem; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT HE MAESTRO 3000 GENERATOR INADVERTENTLY DELIVERED RADIOFREQUENCY (RF) ENERGY. DURING AN ABLATION PROCEDURE FOR RIGHT ATRIAL FLUTTER, USING A "NON-NAV XP CATHETER", THE GENERATOR DELIVERED 40 SECONDS OF RF ENERGY WITHOUT A COMMAND TO DO SO. THE FOOT PEDAL, GENERATOR AND REMOTE WERE UNTOUCHED; "THE RF ENERGY CAME ON ALL BY ITSELF". IT WAS NOT POSSIBLE TO REPRODUCE THE INCIDENT; HOWEVER, IT WAS OBSERVED THAT THE FOOT PEDAL CONNECTION WAS LOOSE IN THE BACK OF THE GENERATOR. THE GENERATOR WAS AT END-OF-LIFE. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH A MAESTRO 4000 GENERATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199158 ↗
• MalfunctionFeb 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AN UNINTENTIONAL ABLATION OCCURRED. A MAESTRO 3000¿ CARDIAC ABLATION SYSTEM CONTROLLER WAS SELECTED FOR A PROCEDURE. INITIALLY DEVICE WOULD NOT ABLATE AND WHILE TROUBLESHOOTING THE DEVICE ABLATED "ON ITS OWN". NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289979 ↗
• MalfunctionFeb 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT INADVERTENT RF DELIVERY OCCURRED. A MAESTRO 3000¿ CARDIAC ABLATION SYSTEM -CONTROLLER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE TURNS ON AND START ABLATING AUTOMATICALLY WITHOUT ASSISTANCE FROM ANYONE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6366352 ↗
• MalfunctionFeb 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT INADVERTENT RF DELIVERY OCCURRED. A MAESTRO 3000 CARDIAC ABLATION SYSTEM -CONTROLLER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE TURNS ON AND START ABLATING AUTOMATICALLY WITHOUT ASSISTANCE FROM ANYONE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6366294 ↗