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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Mechanical Circulatory Support
MAUDE LookupMechanical Circulatory SupportHeartMate

HeartMate Adverse Events: FDA MAUDE Data

Thoratec Corporation · Ventricular Assist Device (LVAD) · First cleared Apr 2008

Total Reports

16,109

Reports (30d)

161

Active Signals

1

Open Recalls

8

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Malfunctioning Mobile Power Unit Returned

unit mpu, power unit, mpu, alarm, mobile power

85

reports

2

Patient Passed Away with Unknown Cause

device therapy, passed away, therapy related, outcome, patient passed

44

reports

3

Device Related Death with No Autopsy

passed away, therapy related, outcome, autopsy performed, patient passed

20

reports

4

Recurrent Driveline Power Fault Alarm

fault, driveline, modular, driveline power, modular cable

19

reports

5

Controller Defect Leading to Exchange

battery, backup, controller exchanged, exchanged, cable

14

reports

6

Modular Cable Damage at Clinic Visit

driveline, modular, damage, clinic, modular cable

12

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

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.

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 I

Jun 23, 2025 · Open, Classified

Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.

Class I

Jun 23, 2025 · Open, Classified

Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

→

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

→
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.