HVAD® Controller 1403USRecalls & reported problems

Summary

The FDA's MAUDE database contains 548 adverse event reports that list this exact device (DI 00888707006859), received between Dec 10, 2019 and Sep 23, 2026 — classified as 26 injuries, 522 malfunctions.

The most frequently reported specific device problem is “Power Problem” (213 reports).

60 other recalls cover devices cleared under the same FDA submission (P100047); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 548 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER ISSUED A CONTROLLER FAULT ALARM DUE TO THE INTERNAL BATTERY REACHING END OF LIFE. 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 23728990 ↗
• MalfunctionNov 24, 2025Disconnection; Power Problem; Disconnection; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED AN UNEXPECTED POWER LOSS. 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 23634684 ↗
• MalfunctionNov 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. 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 23511530 ↗
• MalfunctionOct 15, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT 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 23280599 ↗
• MalfunctionAug 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO DEPLETION OF THE INTERNAL BATTERY. THE ISSUE WAS RESOLVED WITH A CONTROLLER EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912668 ↗
• MalfunctionAug 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. THE SITE DECIDED TO PERMANENTLY SILENCE THE ALARM. 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 22912594 ↗
• MalfunctionAug 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. 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 22894905 ↗
• MalfunctionAug 21, 2025Disconnection; Power Problem; Disconnection; Power Problem

  IT WAS FURTHER REPORTED THAT THE LOSS OF POWER EVENT OCCUR DUE TO A DOUBLE DISCONNECTION OF BOTH POWER SOURCES BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862088 ↗
• MalfunctionJul 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT WITH A PIONEER CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM. THE ALARM WAS CAUSED BY THE INTERNAL BATTERY REACHING END OF LIFE. AFTER THE AUDIO WAS PERMANENTLY SILENCED, THERE WAS NO SINGLE BEEP WHEN A POWER SOURCE WAS ADDED. THE CONTROLLER REMAINS IN USE. NO PATIENT SYMPTOMS, COMPLICATIONS, OR INJURIES WERE REPORTED AS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610933 ↗
• MalfunctionJul 24, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT REVIEW OF LOG FILE DATA REVEALED THE CONTROLLER EXHIBITED A LOSS OF POWER. IT WAS ALSO REPORTED THAT IT IS UNKNOWN WHAT CAUSED THE 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 22587743 ↗
• MalfunctionJul 21, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT UNDERWENT A CONTROLLER EXCHANGE FOR A CONTROLLER FAULT ALARM DUE TO THE DEPLETED INTERNAL BATTERY. VAD COORDINATOR REPORTED THAT THE PATIENT TOLERATED THE EXCHANGE WELL AND THE VAD RESTARTED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560071 ↗
• MalfunctionJul 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM. THE CONTROLLER WAS EXCHANGED TO THE PATIENT¿S BACKUP CONTROLLER BY A NURSE AT THE REHAB HOSPITAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480362 ↗
• MalfunctionJul 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) AFTER A CONTROLLER FAULT ALARM SOUNDED AND WAS ADMITTED. THE PATIENT HAD NO NEW SYMPTOMS OR COMPLAINTS. THE CONTROLLER WAS EXCHANGED AND THE PATIENT WAS DISCHARGED HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461716 ↗
• MalfunctionJul 7, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER ALARMED WITH A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. THE ISSUE WAS RESOLVED WITH A CONTROLLER EXCHANGE IN CLINIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413053 ↗
• MalfunctionJun 24, 2025Battery Problem; Connection Problem; Battery Problem; Connection Problem

  IT WAS REPORTED THAT A PATIENT WITH A PIONEER CONTROLLER EXPERIENCED AN UNSTABLE AND POOR MECHANICAL CONNECTION AT THE DRIVELINE, WHICH WAS ASSOCIATED WITH A CONTROLLER EXCHANGE DUE TO A CONTROLLER FAULT ALARM AND AN INTERNAL BATTERY END OF LIFE NOTIFICATION. THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT FOR A CONTROLLER EXCHANGE. DURING THE INITIAL ATTEMPT TO CONNECT A NEW CONTROLLER, THE CONNECTION WAS UNSUCCESSFUL, SO THE OLD CONTROLLER WAS RECONNECTED, WHICH RESTARTED THE PUMP. ANOTHER CONTROLLER WAS THEN GATHERED, PROGRAMMED, AND A SUCCESSFUL CONTROLLER EXCHANGE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321247 ↗
• MalfunctionJun 23, 2025Low Audible Alarm; Low Audible Alarm

  IT WAS REPORTED THAT A LOW HUMMING SOUND WAS HEARD COMING FROM THE CONTROLLER EQUIPMENT WHILE THE PATIENT WAS LYING ON THEIR ABDOMEN WITH THE CONTROLLER AND POWER SOURCES BENEATH THEM. THE HUMMING STOPPED WHEN THE PATIENT CHANGED POSITION AND WAS NO LONGER LYING ON TOP OF THE EQUIPMENT. NO ALARMS OR OTHER PROBLEMS WERE REPORTED, AND NO FURTHER HUMMING WAS HEARD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308122 ↗
• MalfunctionJun 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT AN UNKNOWN CONTROLLER ALARM OCCURRED AND A CONTROLLER EXCHANGE WAS PERFORMED AT HOME AGAINST MEDICAL ADVICE, REPLACING THE ALARMING CONTROLLER WITH THE BACKUP CONTROLLER, AFTER WHICH THE VENTRICULAR ASSIST DEVICE (VAD) STARTED WITHOUT ISSUES. THE PATIENT WAS RARELY SEEN BY CLINICIANS AND WAS RELUCTANT TO COME TO THE HOSPITAL. THE PATIENT CONTACTED THE CARE TEAM AFTER EXPERIENCING THE ALARM, AND DISCONNECTED AND RECONNECTED BOTH POWER SOURCES, WHICH RESOLVED THE ALARM AND RESTARTED THE VAD, BUT THE PATIENT WAS UNABLE TO SPECIFY WHICH ALARM HAD OCCURRED. THE CARE TEAM ADVISED THE PATIENT TO COME TO THE HOSPITAL FOR A PROPER CONTROLLER EXCHANGE AND TO DOWNLOAD LOGFILES. A NEW CONTROLLER WAS SENT TO SERVE AS THE BACKUP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169491 ↗
• MalfunctionJun 3, 2025Battery Problem; Battery Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133200 ↗
• InjuryJun 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF CARDIOMYOPATHY EXPERIENCED A CONTROLLER FAULT ALARM WITH THE PIONEER CONTROLLERS DUE TO THE INTERNAL BATTERY REACHING END OF LIFE. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR A CONTROLLER EXCHANGE. THE ISSUE WAS RESOLVED BY EXCHANGING THE CONTROLLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124321 ↗
• MalfunctionMay 16, 2025Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE SITE ENDED UP JUST PERMANENTLY SILENCING THE CONTROLLER ALARM. IT WAS ALSO STATED THAT THE PATIENT HAS BEEN FINE SO FAR AND ACTUALLY JUST HAD A FOLLOW UP APPOINTMENT LAST WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036534 ↗
• MalfunctionMay 14, 2025Pumping Stopped; Use of Device Problem; Power Problem; Pumping Stopped; Use of Device Problem; Power Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CONGESTIVE HEART FAILURE EXPERIENCED AN ACCIDENTAL DOUBLE POWER DISCONNECT OF THE CONTROLLER, RESULTING IN THE CONTROLLER BEING OFF FOR APPROXIMATELY 19 SECONDS. DURING THIS TIME, THE VENTRICULAR ASSIST DEVICE (VAD) STOPPED BUT RESUMED OPERATION ONCE THE CONTROLLER WAS POWERED BACK UP. THE PATIENT WAS REEDUCATED ON POWER SOURCE MANAGEMENT. THE CONTROLLER REMAINS IN USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021546 ↗
• InjuryMay 14, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT MULTIPLE CONTROLLER FAULT ALARMS OCCURRED DUE TO THE INTERNAL BATTERY END OF LIFE. A SUCCESSFUL CONTROLLER EXCHANGE WAS PERFORMED IN THE HOSPITAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021333 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100047. One submission often covers many models, so check the product and lot details in each record.

• Z-0475-2024 · Oct 31, 2023 · Open, Classified
  HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
• Z-1993-2023 · May 16, 2023 · Open, Classified
  HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
• Z-1512-2022 · Jun 28, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• Z-1266-2022 · May 5, 2022 · Open, Classified
  HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
• Z-1207-2022 · Apr 14, 2022 · Open, Classified
  HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1110-2022 · Mar 30, 2022 · Open, Classified
  Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump
• Z-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1107-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) H
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-0726-2022 · Jan 27, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System
• Z-2478-2021 · Aug 6, 2021 · Open, Classified
  Medtronic HVAD Pump Implant Kits
• Z-2191-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1153

…and 45 more.