Maestro 4000™ Controller M0044000H0Recalls & reported problems
Boston Scientific Corporation · RF Cardiac Ablation Controller · Class 3
All models of Maestro 4000 Controller (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729861935), received between Oct 17, 2019 and Oct 17, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Remains Activated” (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 16, 2026.
Most reported problems
Device problems
- Device Remains Activated3
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2019Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THERE WAS A FAILURE TO HALT RADIOFREQUENCY (RF) ABLATION DELIVERY. DURING AN ABLATION PROCEDURE, WHILE ABLATING WITH THE FOOT PEDAL, ENERGIZATION CONTINUED EVEN WHEN THE FOOT PEDAL WAS REMOVED. ENERGIZATION WAS STOPPED VIA AN OFF SWITCH ON THE MAIN UNIT. THERE WERE NO REPORTED PATIENT ISSUES AND THE PATIENT OUTCOME WAS "GOOD."
Patient problems: No Patient Involvement
MAUDE report 9203586 ↗MalfunctionOct 17, 2019Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THERE WAS A FAILURE TO HALT RADIOFREQUENCY (RF) ABLATION DELIVERY. DURING AN ABLATION PROCEDURE, WHILE ABLATING WITH THE FOOT PEDAL, ENERGIZATION CONTINUED EVEN WHEN THE FOOT PEDAL WAS REMOVED. ENERGIZATION WAS STOPPED VIA AN OFF SWITCH ON THE MAIN UNIT. THERE WERE NO REPORTED PATIENT ISSUES AND THE PATIENT OUTCOME WAS "GOOD."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9203561 ↗MalfunctionOct 17, 2019Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THERE WAS A FAILURE TO HALT RADIOFREQUENCY (RF) ABLATION DELIVERY. DURING AN ABLATION PROCEDURE, WHILE ABLATING WITH THE FOOT PEDAL, ENERGIZATION CONTINUED EVEN WHEN THE FOOT PEDAL WAS REMOVED. ENERGIZATION WAS STOPPED VIA AN OFF SWITCH ON THE MAIN UNIT. THERE WERE NO REPORTED PATIENT ISSUES AND THE PATIENT OUTCOME WAS "GOOD."
Patient problems: No Patient Involvement
MAUDE report 9203558 ↗
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- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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