HVAD® Controller 1420 (UDI 00888707000420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,161 adverse event reports that list this exact device (DI 00888707000420), received between Oct 2, 2017 and Nov 24, 2025 — classified as 14 deaths, 65 injuries, 2,082 malfunctions.

The most frequently reported specific device problem is “Power Problem” (1,219 reports).

5 FDA recall records name this device's identifier, 5 still open.

55 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. 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 · 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-1105-2022 · Root cause: Labeling design · FDA record ↗

3. 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 ↗

4. 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 ↗

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,161 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Use of Device Problem; Battery Problem; Power Problem; Use of Device Problem; Battery Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER EXHIBITED DOUBLE DISCONNECT DUE TO POWER EXCHANGE BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635092 ↗
• MalfunctionNov 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM. 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 23513405 ↗
• MalfunctionSep 12, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO DEPLETION OF THE 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 23039205 ↗
• MalfunctionAug 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT TWO PIONEER CONTROLLERS WERE SUSPECTED TO HAVE INTERNAL BATTERY FAILURE. IT WAS NOTED THAT BOTH OF THE CONTROLLERS WERE VERY OLD. THE CONTROLLERS REMAIN IN USE AND REPLACEMENT OF THE CONTROLLERS WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895858 ↗
• MalfunctionJul 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PIONEER CONTROLLERS EXPERIENCED A CONTROLLER FAULT ALARM DUE TO DEPLETION OF THE INTERNAL BATTERY. THE ISSUE HAD ORIGINALLY BEEN PERMANENTLY SILENCED, BUT WAS UNINTENTIONALLY REACTIVATED AFTER A DOUBLE POWER-UP EVENT. THE ALARM WAS PERMANENTLY SILENCED AS A RESOLUTION. 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 22621194 ↗
• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  THE CONTROLLER WAS RETURNED TO THE MANUFACTURER. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED A MECHANICAL PROBLEM WAS IDENTIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340975 ↗
• MalfunctionJun 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CARDIOMYOPATHY EXPERIENCED AN ALARM WITH THE CONTROLLER, SPECIFICALLY A CONTROLLER FAULT ALARM ATTRIBUTED TO A DEPLETED INTERNAL BATTERY. THE PATIENT PERFORMED A CONTROLLER EXCHANGE AT HOME, RESTARTING THE VENTRICULAR ASSIST DEVICE (VAD) ON THE BACKUP CONTROLLER, WHICH WAS NOTED TO BE VERY OLD. THE PATIENT WAS EVALUATED IN THE CLINIC AND RETURNED THE ORIGINAL CONTROLLER TO THE VAD TEAM. LOGFILES WERE INITIALLY UNABLE TO BE DOWNLOADED DUE TO A NON-FUNCTIONING VAD MONITOR AT THE SITE, BUT WERE LATER OBTAINED AND REVIEWED, CONFIRMING THE CONTROLLER FAULT ALARM WAS DUE TO THE 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 22206038 ↗
• InjuryMay 23, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM INDICATING THE INTERNALLY BATTERY END OF LIFE. THE PATIENT CAME INTO THE CLINIC, AND AUTOLOGS REPORTED TWO CONTROLLER FAULT ALARMS. A SUCCESSFUL CONTROLLER EXCHANGE WAS PERFORMED IN THE INTENSIVE CARE UNIT, WITH THE CLINICIAN EXCHANGING THE OLD CONTROLLER FOR A NEW PRIMARY CONTROLLER, AND THE VENTRICULAR ASSIST DEVICE (VAD) STARTED RIGHT UP. THE OLD CONTROLLER WAS DISPOSED OF BY THE CLINICIAN AND WILL NOT BE RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22079007 ↗
• MalfunctionMay 23, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PIONEER CONTROLLER EXPERIENCED AN ALARM AND A CONTROLLER FAULT ALARM DUE TO AN INTERNAL BATTERY END OF LIFE. THE ALARM WAS ONCE PREVIOUSLY SILENCED BUT REAPPEARED LATER. THE ISSUE WAS RESOLVED THROUGH 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 22078964 ↗
• MalfunctionMay 21, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A CONTROLLER FAULT OCCURRED WITH THE PIONEER CONTROLLERS DUE TO AN INTERNAL BATTERY DEPLETION. A CONTROLLER EXCHANGE WAS SCHEDULED. THE CONTROLLER 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 22061976 ↗
• MalfunctionApr 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXPERIENCED CONTROLLER FAULT ALARMS, INDICATING THE INTERNAL BATTERY END OF LIFE. THE CONTROLLER EXCHANGE WAS DONE SUCCESSFULLY, AND THE BACKUP CONTROLLER WAS PROPHYLACTICALLY EXCHANGED AS WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921389 ↗
• MalfunctionApr 3, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE BATTERY EXHIBITED POWER DISCONNECT ALARM. THE BATTERY WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763892 ↗
• MalfunctionMar 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXPERIENCED A CONTROLLER FAULT ALARM, INDICATING THE INTERNAL BATTERY HAD REACHED THE END OF ITS LIFE. THE ISSUE WAS RESOLVED BY EXCHANGING THE CONTROLLER WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690488 ↗
• MalfunctionMar 4, 2025Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED MULTIPLE LOSSES OF POWER TO THE CONTROLLER. 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 21515362 ↗
• MalfunctionFeb 21, 2025Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE CONTROLLER HAD POOR/UNSTABLE MECHANICAL CONNECTION DUE TO BENT PINS IN THE POWER PORT. IT IS UNKNOWN IF EXCESSIVE FORCE WAS USED WHEN TRYING TO CONNECT THE CONTROLLER. THE CONTROLLER WAS EXCHANGED AT HOME AS THE PATIENT LIVES IN A REMOTE LOCATION AND IS ON HOSPICE CARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433868 ↗
• MalfunctionFeb 20, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A CONTROLLER FAULT ALARM OCCURRED WITH THE PIONEER CONTROLLER DUE TO THE INTERNAL BATTERY END OF LIFE. THE CONTROLLER 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 21426903 ↗
• MalfunctionFeb 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO THE INTERNAL BATTERY REACHING THE END OF LIFE. THE VENTRICULAR ASSIST DEVICE COORDINATOR ADDRESSED THE ALARM BY SILENCING IT AND DECIDED NOT TO EXCHANGE THE CONTROLLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405655 ↗
• MalfunctionFeb 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PIONEER CONTROLLER WAS INVOLVED IN AN EVENT WHERE A CONTROLLER FAULT ALARM WAS TRIGGERED DUE TO THE INTERNAL BATTERY REACHING THE END OF ITS LIFE. THE ALARM WAS MUTED, AND THERE WAS NO PLAN TO EXCHANGE THE CONTROLLER. THE PATIENT IS INCLUDED IN THE SUBGROUP 1 POPULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396181 ↗
• MalfunctionJan 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED CONTROLLER FAULT ALARMS ATTRIBUTED 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 21056122 ↗
• MalfunctionDec 3, 2024Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER ALARMS WERE SILENCED AND THE UNEXPECTED LOSS OF POWER WAS DUE TO AN ACCIDENTAL DOUBLE DISCONNECT OF POWER SOURCES BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834456 ↗
• MalfunctionNov 26, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO THE INTERNAL BATTERY END OF LIFE. THE ALARM WAS TURNED OF PERMANENTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778479 ↗
• MalfunctionOct 30, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO THE INTERNAL BATTERY END OF LIFE. IT WAS ALSO REPORTED THAT THE PATIENT WAS CONFUSED AND ACCIDENTALLY DISCONNECTED BOTH BATTERIES WHILE RESETTING THE CONTROLLER, AND THAT THE CONTROLLER FAULT ALARM HAD APPEARED AGAIN. THE ALARM WAS PERMANENTLY SILENCED. THE CONTROLLER WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569358 ↗
• MalfunctionOct 23, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER WAS EXHIBITING UNSTABLE/POOR MECHANICAL CONNECTION ON THE POWER PORTS. THE CONTROLLER WAS EXCHANGED. OF NOT: IT WAS MENTIONED THAT IT WAS IMPOSSIBLE TO UNMUTE THE SYSTEM WITH RED ALARM ADAPTER AFTER CONTROLLER EXCHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515130 ↗
• InjuryOct 2, 2024Pumping Stopped; Battery Problem; Power Problem; Pumping Stopped; Battery Problem; Power Problem

  T WAS REPORTED THAT, APPROXIMATELY FOUR MONTHS AGO, THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE AND THE ALARM WAS SUPPRESSED. FOUR MONTHS LATER DURING A BATTERY EXCHANGE, THE BATTERY ON POWER SOURCE 1 EXHIBITED POWER SWITCHING WHICH RESULTED IN A LOSS OF POWER TO THE CONTROLLER AND A VENTRICULAR ASSIST DEVICE (VAD) STOP. ONCE THE BATTERY ON POWER SOURCE 2 WAS RECOGNIZED, THE CONTROLLER POWERED UP AND THE PUMP STARTED. IT WAS ALSO REPORTED THAT ALL OF THE PATIENT'S BATTERIES HAD "SWITCHING ISSUES." IT WAS ALSO REPORTED THAT THE PREVIOUSLY SUPPRESSED CONTROLLER FAULT ALARM WAS RESET AND THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY END OF LIFE. THE PATIENT WAS HOSPITALIZED AS THEY WERE SCARED THE PUMP MIGHT STOP AGAIN. THE BATTERIES WERE REMOVED FROM USE. THE CONTROLLER REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 20353327 ↗
• MalfunctionOct 2, 2024Disconnection; Power Problem; Pumping Problem; Disconnection; Power Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED SEVERAL LOW FLOW ALARMS DUE TO MALPOSITION OF THE INFLOW CANNULA AFTER LEFT VENTRICLE (LV) REMODELING. THE VAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351668 ↗

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-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-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
• Z-2188-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1103
• Z-2191-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1153

…and 40 more.