Thoratec® HeartMate 3™ 106531USRecalls & reported problems
Thoratec Corporation · System Controller · Class 3
All models of Thoratec HeartMate 3 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Thoratec HeartMate 3 system controller is the external controller for a heart pump. Its 4,665 adverse event reports mostly describe battery and power alarms, low-voltage beeps, driveline disconnections and backup battery faults. The reports include 12 deaths and 174 injuries. Reports in the last 12 months number 356, down from 1,098 in the 12 months before. 1 recall names this device: started in June 2024 and still open, it covers a controller screen that can lift at the edge, letting fluid in and causing false or lost alarms.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,646
- Deaths reported
- 11
- Injuries reported
- 174
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,646 adverse event reports that list this exact device (DI 00813024013235), received between Aug 12, 2018 and Sep 30, 2026 — classified as 11 deaths, 174 injuries, 4,459 malfunctions.
The most frequently reported specific device problem is “Electrical Power Problem” (1,306 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 25, 2024Class IIOpen, Classified
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
Z-2583-2024 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Electrical Power Problem1,306
- Disconnection774
- Mechanical Problem733
- Insufficient Device Problem Information566
- Electrical /Electronic Property Problem368
- Material Deformation367
- Failure to Charge326
- Communication or Transmission Problem310
Patient problems
- No Clinical Signs, Symptoms or Conditions4,325
- No Consequences Or Impact To Patient254
- Insufficient Information69
- Electric Shock30
- No Known Impact Or Consequence To Patient30
- Syncope/Fainting17
- Loss of consciousness10
- Dizziness7
Recent adverse event reports
The 25 most recent of 4,646 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Electrical /Electronic Property Problem
There was a yellow-wrench icon on the System Controller. The patient performed System Controller exchange without discussing with their team.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951783 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951606 ↗MalfunctionSep 30, 2026Electrical Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951392 ↗MalfunctionSep 30, 2026Disconnection
It was reported that the patient experienced numerous Power Cable Disconnect Alarms hours apart. It was said that the alarms occurred when the patient was walking, sitting, and lying down. The alarms were said to also have occurred before and after the patient fell while lying on a gurney. Upon initial interrogations the alarms did not appear to show on the System Controller nor Monitor. Log Files were submitted for review and captured unusual Power Cable Disconnect Alarms while the patient was on Battery Power. The alarms appeared to be the result of relative state of charge (RSOC) invalid flags. All connections were checked and different Batteries and two set of clips were tried but the alarms persisted. The alarms resolved when the System Controller was exchanged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951041 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that the patient presented to the clinic with only one of the two green arrows in the Pump Running Symbol illuminated on the System Controller. Log Files were were submitted for evaluation. The Event Log File captured routine events. It was suggested to exchange the Controller.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946835 ↗MalfunctionSep 30, 2026Electrical Power Problem
It was reported that the patient had an Emergency Backup Battery (EBB) Fault Alarm (b)(6) 2026. The System Controller was exchanged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946623 ↗MalfunctionSep 29, 2026Unintended Electrical Shock
Patient problems: Electric Shock
MAUDE report 50938007 ↗MalfunctionSep 29, 2026Mechanical Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937685 ↗MalfunctionSep 29, 2026Electrical Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937468 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935540 ↗MalfunctionSep 29, 2026Mechanical Problem; Communication or Transmission Problem; Electrical Power Problem; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931867 ↗MalfunctionSep 28, 2026Insufficient Device Problem Information
It was reported that patient had a Controller Fault Alarm that was addressed by the healthcare provider.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916658 ↗MalfunctionSep 28, 2026Disconnection; Complete Loss of Power
It was reported that the patient passed away. The cause of death was not provided. The patient detached from power. An autopsy would not be performed. The Pump was not explanted.
Patient problems: Insufficient Information
MAUDE report 50916449 ↗MalfunctionSep 28, 2026Material Twisted/Bent; Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914287 ↗MalfunctionSep 25, 2026Mechanical Problem; Electrical Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903407 ↗MalfunctionSep 25, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902924 ↗MalfunctionSep 25, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902696 ↗MalfunctionSep 25, 2026Disconnection
It was reported that the patient passed away at home. The Event Log File review captured a Driveline Disconnect event at (b)(6)026 2:12:14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900416 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891937 ↗MalfunctionSep 24, 2026Pumping Stopped; Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888768 ↗MalfunctionSep 24, 2026Communication or Transmission Problem; Electrical Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887270 ↗MalfunctionSep 24, 2026Display Difficult to Read
It was reported that the System Controller was replaced because vertical lines appeared on the System Controller display.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886587 ↗MalfunctionSep 24, 2026Display Difficult to Read; Noise, Audible
It was reported that the System Controller was exchanged due to an abnormal alarm sound during the self-test and vertical line noise on the display. There were no patient consequences. The event resolved with exchange.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886533 ↗MalfunctionSep 24, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885576 ↗MalfunctionSep 24, 2026Failure to Charge
It was reported that the patient had been having Emergency Backup Battery (EBB) Faults/ replace Backup Battery Alarms since the night before. The EBB was replaced, but yellow wrench alarms/ EBB Faults were still occurring. The Log captured EBB Faults Alarms starting from (b)(6) 2026 at 2304 and continued for the remainder of the Log Files. The EBB Fault was due to the EBB failing the load test. It was intended to exchange the System Controller.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884707 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
- HeartWare® Controller 1403USHeartware Inc. · Ventricular (Assisst) Bypass3 recalls10 deaths1,495 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 · each recall links to the FDA recall notice
- 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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