HeartWare® Controller 1403US (UDI 00888707000475)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,495 adverse event reports that list this exact device (DI 00888707000475), received between Oct 31, 2017 and Oct 17, 2025 — classified as 10 deaths, 42 injuries, 1,443 malfunctions.

The most frequently reported specific device problem is “Power Problem” (789 reports).

3 FDA recall records name this device's identifier, 3 still open.

57 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.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,495 reports, 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 ↗
• MalfunctionMay 6, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO THE INTERNAL BATTERY END OF LIFE. 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 19248212 ↗
• MalfunctionMay 2, 2024Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS FURTHER REPORTED THAT THE EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231176 ↗
• MalfunctionMay 2, 2024Disconnection; 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 19231165 ↗
• MalfunctionMar 20, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM ATTRIBUTED TO A DEPLETED INTERNAL BATTERY. 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 18941113 ↗
• MalfunctionMar 7, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM, INDICATING THE END-OF-LIFE OF THE INTERNAL BATTERY. 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 18856566 ↗
• MalfunctionFeb 29, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM. THE PATIENT WENT TO THE HOSPITAL AND LOG FILES WERE SUBMITTED FOR REVIEW. REVIEW OF LOG FILE DATA INDICATED THAT THE CONTROLLER FAULT WAS DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS EXCHANGED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809077 ↗
• MalfunctionFeb 14, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A CONTROLLER FAULT ALARM DUE TO THE DEPLETION OF THE INTERNAL BATTERY. THE PATIENT INTERNATIONAL NORMALIZED RATIO (INR) WAS FOUND TO BE SUBTHERAPEUTIC WITH A RESULT OF 2.37, AND THE LACTATE DEHYDROGENASE (LDH) 356. THE CONTROLLER WAS EXCHANGED, AND THE PATIENT WAS RELEASED THE SAME DAY WITHOUT BEING ADMITTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Lactate Dehydrogenase Increased

  MAUDE report 18705197 ↗
• MalfunctionSep 29, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. 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 17847914 ↗
• MalfunctionSep 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED TWO CONTROLLER FAULT ALARMS INDICATING INTERNAL BATTERY END OF LIFE. THE CONTROLLER WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726706 ↗
• MalfunctionAug 30, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. 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 17656721 ↗

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-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• 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-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• 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-2195-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF MCS1705PU

…and 42 more.