HEARTMATE POWER MODULE (NA) Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared May 2013

Total Reports

476

Reports (30d)

7

Active Signals

0

Open Recalls

11

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

External Power Loss with Controller Battery Depletion

log files, battery, controller, files, power

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

FDA recalls for this device

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

May 13, 2026 · Open, Classified

Due to 11 volt Backup Battery failures.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Class II

Oct 9, 2025 · Open, Classified

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.