HVAD ControllerRecalls & reported problems across all models

We found 3 models of HVAD Controller by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 2,990 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2017 and Sep 30, 2026 — classified as 14 deaths, 101 injuries, 2,875 malfunctions.

The most frequently reported specific device problem is “Power Problem” (1,565 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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

HVAD 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. Mar 30, 2022Open, Classified

   Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

   Z-1105-2022 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

2. Mar 30, 2022Open, Classified

   Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

   Z-1104-2022 · Root cause: Labeling design · Recall details · FDA record ↗

3. 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 ↗

4. 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 ↗

5. 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 · Recall details · FDA record ↗

Most reported HVAD Controller problems

HVAD Controller models

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

• HVAD® Controller 1420

  Ventricular (Assisst) Bypass
  5 recalls14 deaths2,161 reports
• HVAD® Controller 1403US

  Ventricular (Assist) Bypass
  548 reports
• HVAD® Controller 1420

  Ventricular (Assist) Bypass
  1 recall281 reports

Recent HVAD Controller adverse event reports

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

• MalfunctionSep 30, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952780 ↗
• MalfunctionSep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923433 ↗
• MalfunctionSep 23, 2026Power Problem

  Upon review of log file data it was identified that the controller exhibited controller loss of power. 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 50870891 ↗
• MalfunctionSep 23, 2026Data Problem

  It was reported that log files were sent in for review, but a report could not be generated because insufficient or incomplete data was received. There may have been an incomplete download or data transfer from the controller to the monitor. 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 50869896 ↗
• MalfunctionSep 16, 2026Electrical /Electronic Property Problem; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793942 ↗
• MalfunctionSep 8, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675385 ↗
• MalfunctionSep 8, 2026Power Problem

  It was reported that review of log file data revealed a controller unexpected loss of power.  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 50670478 ↗
• MalfunctionJan 26, 2026Use of Device Problem; Battery Problem; Power Problem

  IT WAS REPORTED THAT A CONTROLLER FAULT ALARM OCCURRED DUE TO INTERNAL BATTERY DEPLETION. SUBSEQUENTLY, A DOUBLE POWER DISCONNECT EVENT OCCURRED DUE TO THE PATIENT MANIPULATION ERROR, CAUSING THE CONTROLLER FAULT ALARM TO SOUND AGAIN. THE CONTROLLER FAULT ALARM WAS PERMANENTLY MUTED AGAIN. 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 24179951 ↗
• MalfunctionJan 22, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A DOUBLE DISCONNECT OF POWER SOURCES, WHICH WAS ATTRIBUTED TO PATIENT CONFUSION. THE CONTROLLER REMAINS IN USE. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Confusion/ Disorientation

  MAUDE report 24148688 ↗
• MalfunctionJan 22, 2026Use of Device Problem; Power Problem

  IT WAS REPORTED THAT A REVIEW OF LOG FILE DATA REVEALED THE CONTROLLER EXHIBITED AN UNEXPECTED LOSS OF POWER. 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 24147118 ↗
• MalfunctionJan 15, 2026Battery Problem

  IT WAS REPORTED THAT A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. THE ALARM WAS CONFIRMED, AND 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 24083250 ↗
• MalfunctionJan 13, 2026Data Problem

  IT WAS REPORTED THAT A DATA TRANSFER ERROR OCCURRED WHEN DOWNLOADING THE LOGFILES FROM THE CONTROLLER TO THE MONITOR. INSUFFICIENT OR INCOMPLETE LOG DATA WAS RECEIVED TO GENERATE A REPORT. 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 24055185 ↗
• InjuryJan 9, 2026Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY DEPLETION. THE PATIENT WAS ADMITTED AND 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 24021093 ↗
• MalfunctionJan 6, 2026Battery Problem; Power Problem

  IT WAS REPORTED THAT A CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. THE PATIENT WAS ADMITTED TO HOSPITAL AND THE CONTROLLER FAULT ALARM WAS SILENCED. THE SITE PLANNED AND SUCCESSFULLY PERFORMED A CONTROLLER EXCHANGE. DURING THE EXCHANGE TO THE NEW CONTROLLER A LOSS OF POWER WAS NOTED. THE VAD 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 23975720 ↗
• MalfunctionJan 5, 2026Battery Problem

  IT WAS REPORTED THAT A CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM WHICH WAS ATTRIBUTED TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER FAULT ALARM WAS SUBSEQUENTLY SILENCED AND 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 23960694 ↗

Other Heartware Inc. products

• HVAD Pump Implant Kit5 models · 5,895 reports · 11 recalls
• HeartWare Battery11 models · 4,241 reports · 5 recalls
• HeartWare Controller2 models · 2,393 reports · 3 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