Maestro 4000™ Pod, 100W M00440100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729861966), received between Nov 19, 2020 and Jan 8, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (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.

• MalfunctionJan 8, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, A MAESTRO 4000 POD, 100W WAS SELECTED FOR USE. THE POD IS REGISTERING LOW TEMPERATURES. DIFFERENT POD WAS USED AND THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108172 ↗
• MalfunctionAug 17, 2023Temperature Problem; Temperature Problem

  DURING AN ABLATION PROCEDURE, A MAESTRO 4000 POD WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING PROCEDURE THE DEVICE KEPT SHUTTING OFF DUE TO LOW TEMPERATURE WARNINGS. THIS HAPPENED AFTER SEVERAL ABLATIONS PERFORMED SUCCESSFULLY. WHEN THE PHYSICIAN WANTED TO APPLY HIGHER POWER AT 40W, THE GENERATOR WOULD STOP ABLATION RIGHT AFTER HIGH POWER WAS SET. THE STARTING TEMPERATURES DURING THE ERRORS WAS AVERAGING 23 DEGREES. THE HIGHER FLOW RATE FROM THE METRIQ PUMP WOULD RESULT IN THE TEMPERATURE DROPPING TO 15 DEGREES RAPIDLY. THE PHYSICIAN COULD NOT ABLATE AT HIS DESIRED POWERS. THE POD WAS PULLED FROM UNDER THE PATIENT DRAPE. THE PHYSICIAN ENDED THE PROCEDURE BEFORE ANY MORE TROUBLESHOOTING STEPS COULD BE ATTEMPTED. PATIENT COMPLICATIONS ARE UNKNOWN AS WELL AS PRODUCT RETURN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564557 ↗
• MalfunctionDec 7, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE WITH AN MAESTRO 4000 POD, ERROR CODE "D09: SUSPECT POD" WAS OBSERVED. THE ERROR WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS CANCELLED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954656 ↗
• MalfunctionDec 7, 2021Defective Device; Temperature Problem; Defective Device; Temperature Problem

  DURING A PROCEDURE A MAESTRO 4000 POD WAS SELECTED FOR USE. IT WAS REPORTED THAT WHEN THE ABLATION CATHETER WAS INSERTED INTO THE PATIENT, THE TEMPERATURE READING WAS 10 DEGREES CELSIUS COLDER THAN HUMAN BODY TEMPERATURE. THE POD WAS EXCHANGED AND THE TEMPERATURE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953601 ↗
• MalfunctionNov 19, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A MAESTRO 4000 POD WAS USED IN A AV NODE ABLATION PROCEDURE. DURING THE PROCEDURE INTERMITTENT D08 'CHECK POD' ERROR OCCURRED DURING THE PROCEDURE. IT WAS FURTHER REPORTED ON (B)(6) 2020 THAT THE PROCEDURE WAS CANCELED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10869433 ↗