Maestro 4000™ Remote Control M00440200Recalls & reported problems
Boston Scientific Corporation · RF Cardiac Ablation Remote Control · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729862062), received between Jun 20, 2018 and Jun 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (2 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.
Reports received per month
Most reported problems
Device problems
- Device Remains Activated2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Device Remains Activated; Defective Device; Device Remains Activated; Defective Device
IT WAS REPORTED THAT THE STOP BUTTON OF THE MAESTRO 4000 REMOTE CONTROL IS NOT WORKING THE CONTROLLER DID NOT HALT ABLATION, AND THE STAFF HAD TO SWITCH IT OFF FOR STOP. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19556885 ↗MalfunctionJun 20, 2018Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE REMOTE CONTROL WOULD NOT STOP ABLATION. DURING AN ABLATION PROCEDURE, A MAESTRO 4000¿ REMOTE CONTROL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE REMOTE CONTROL WOULD NOT STOP ABLATION. THE REMOTE HAD TO BE TURNED OFF TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7619865 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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