HeartWare ControllerRecalls & reported problems across all models

We found 2 models of HeartWare Controller by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 2,393 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2016 and Oct 17, 2025 — classified as 15 deaths, 47 injuries, 2,330 malfunctions.

The most frequently reported specific device problem is “Power Problem” (1,055 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HeartWare Controller recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

   Z-1438-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

   Z-1469-2021 · Root cause: Device Design · Recall details · FDA record ↗

3. May 2, 2018Open, Classified

   Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

   Z-1903-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported HeartWare Controller problems

HeartWare Controller models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartWare® Controller 1403US

  Ventricular (Assisst) Bypass
  3 recalls10 deaths1,495 reports
• HeartWare® Controller 1403US

  Ventricular (Assisst) Bypass
  1 recall5 deaths898 reports

Recent HeartWare Controller adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THERE WERE TWO INSTANCES IN THE LAST FEW WEEKS WHERE THERE WAS A RED ALARM WHILE CHANGING THE BATTERIES ON THE CONTROLLER. IT WAS NOTED THAT AFTER THE PATIENT REPORTED THE "RED ALARM" DURING POWER CONNECTIONS, FREQUENT MISCOMMUNICATIONS WITH THE BATTERIES WERE NOTED IN THE LOG FILES. POWER SWITCHING WAS SUSPECTED. THE CONTROLLER AND BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325716 ↗
• MalfunctionSep 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PIONEER CONTROLLER GENERATED A NO POWER ALARM WHEN BOTH POWER SOURCES WERE ACCIDENTALLY DISCONNECTED FROM THE CONTROLLER AT THE SAME TIME. THE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954709 ↗
• MalfunctionAug 26, 2025Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED AN UNEXPECTED LOSS OF POWER AND A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894886 ↗
• MalfunctionApr 29, 2025Pumping Stopped; Battery Problem; Connection Problem; Pumping Stopped; Battery Problem; Connection Problem

  IT WAS REPORTED THAT A PIONEER CONTROLLER WAS INVOLVED IN AN EVENT WHERE A CONTROLLER FAULT ALARM OCCURRED DUE TO A DEPLETED INTERNAL BATTERY. THE VENTRICULAR ASSIST DEVICE (VAD) STOPPED, AND DISCONNECT ALARMS WERE NOTED. THE VAD STOP AND VAD DISCONNECT ALARMS ON THE CONTROLLER WERE TRIGGERED BECAUSE THE CONTROLLER WAS POWERED UP WITHOUT USING THE "DISABLE VAD STOP" OPTION DURING PROGRAMMING. THE PATIENT HAD A MEDICAL HISTORY OF CARDIOMYOPATHY. THE CONTROLLER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928294 ↗
• MalfunctionMar 24, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM OCCURRED DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS EXCHANGED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677250 ↗
• MalfunctionFeb 3, 2025Use of Device Problem; Battery Problem; Power Problem; Pumping Problem; Use of Device Problem; Battery Problem; Power Problem; Pumping Problem

  IT WAS REPORTED THAT A PIONEER CONTROLLER WAS INVOLVED IN AN EVENT WHERE A CONTROLLER FAULT ALARM OCCURRED, PRESUMABLY DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS EXCHANGED IN THE EMERGENCY ROOM AT A HOSPITAL, AND THE PUMP WAS RESTARTED WITHOUT ISSUE. THE PATIENT, WAS WITHOUT SYMPTOMS AND REMAINED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293821 ↗
• MalfunctionJan 23, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A REVIEW OF LOG FILE DATA REVEALED A CONTROLLER FAULT ALARM RELATED TO THE INTERNAL BATTERY. THE ALARM WAS PERMANENTLY SILENCED ON (B)(6) 2023, DUE TO THE PATIENT'S INELIGIBILITY FOR A VAD EXCHANGE. THE PATIENT IS ELDERLY AND FRAIL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219631 ↗
• MalfunctionJan 2, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT REVIEW OF LOG FILE DATA FOUND THAT THE CONTROLLER HAD A LOSS OF POWER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056198 ↗
• MalfunctionNov 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE THE PATIENT WAS HOSPITALIZED STAFF IMPROPERLY CONNECTED POWER SOURCES AND BENT PINS ON THE CONTROLLER, CAUSING AN UNSTABLE CONNECTION. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663439 ↗
• MalfunctionOct 18, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481832 ↗
• MalfunctionOct 2, 2024Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE LOSS OF POWER WAS DUE TO AN ACCIDENTAL DOUBLE DISCONNECT OF POWER BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351856 ↗
• MalfunctionSep 4, 2024Electrical /Electronic Property Problem; Battery Problem; Power Problem; Pumping Problem; Electrical /Electronic Property Problem; Battery Problem; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER FAULT ALARM WAS DUE TO THE INTERNAL BATTERY END OF LIFE, AND THE ALARM RESOLVED AS THE BATTERY VOLTAGE ROSE ABOVE THE THRESHOLD. IT WAS ALSO REPORTED THAT REVIEW OF LOG FILE DATA REVEALED THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED MOTOR START EVENTS WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE, THE CONTROLLER EXHIBITED AN UNEXPECTED POWER LOSS, AND A BATTERY EXHIBITED COMMUNICATION ERROR. THE CONTROLLER WILL BE RETURN, THE VAD REMAINS IN USE, AND THE BATTERY WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136929 ↗
• MalfunctionAug 21, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018227 ↗
• MalfunctionJul 23, 2024Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807200 ↗
• MalfunctionMay 14, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY.  THE CONTROLLER WAS PERMANENTLY SILENCED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310749 ↗

Other Heartware Inc. products

• HVAD Pump Implant Kit5 models · 5,895 reports · 11 recalls
• HeartWare Battery11 models · 4,241 reports · 5 recalls
• HVAD Controller3 models · 2,990 reports · 5 recalls
• Patient Pack2 models · 224 reports · 2 recalls
• HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
• HVAD Pump Outflow Graft3 models · 60 reports · 2 recalls
• HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
• HeartWare Controller DC Adapter6 models · 59 reports · 1 recall