HVAD® Controller 1420 (UDI 00888707007658)Recalls & reported problems

Summary

The FDA's MAUDE database contains 281 adverse event reports that list this exact device (DI 00888707007658), received between Apr 21, 2021 and Sep 30, 2026 — classified as 10 injuries, 271 malfunctions.

The most frequently reported specific device problem is “Power Problem” (133 reports).

1 FDA recall record name this device's identifier, 1 still open.

59 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-1105-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 281 reports, 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 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 ↗
• 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 ↗
• MalfunctionDec 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED AN ALARM, SPECIFICALLY A CONTROLLER FAULT ALARM, DUE TO DEPLETION OF THE INTERNAL BATTERY. 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 23896241 ↗
• MalfunctionDec 23, 2025Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE LOSS OF POWER OCCURRED DUE TO A DOUBLE DISCONNECTION OF BOTH POWER SOURCES BY THE PATIENT. THE PATIENT WAS CONVERTING FROM WALL POWER TO BATTERY AND ACCIDENTALLY DISCONNECTED BOTH POWER SOURCES. NO ISSUE WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878196 ↗
• MalfunctionDec 22, 2025Battery 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 23864399 ↗
• MalfunctionDec 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM. THE PATIENT REFUSED A CONTROLLER EXCHANGE SO THE SITE PERMANENTLY SILENCED THE CONTROLLER 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 23839679 ↗
• MalfunctionDec 16, 2025Battery 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 23818792 ↗
• MalfunctionDec 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CONTROLLER FAULT AT HOME AND PERFORMED A CONTROLLER EXCHANGE TO THE BACKUP CONTROLLER AT HOME. 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 23805239 ↗
• MalfunctionDec 11, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO INTERNAL BATTERY DEPLETION. THE ALARM WAS PERMANENTLY SILENCED. AT THIS TIME, THE SITE IS NOT PLANNING TO PERFORM A CONTROLLER EXCHANGE. THE CONTROLLER REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778605 ↗
• MalfunctionDec 10, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM INDICATING A DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS EXCHANGED WITH A NEW CONTROLLER. THE VENTRICULAR ASSIST DEVICE (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 23767908 ↗
• MalfunctionDec 8, 2025Disconnection; Power Problem; Disconnection; Power Problem

  IT WAS FURTHER REPORTED THAT 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 23751416 ↗
• MalfunctionDec 4, 2025Battery Problem; Pumping Problem; Battery Problem; Pumping Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER WAS EXCHANGED. REVIEW OF LOG FILES REVEALED A MOTOR START WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE ASSOCIATED WITH THE CONTROLLER EXCHANGE. THE VAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716301 ↗
• MalfunctionDec 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO AN INTERNAL BATTERY END OF LIFE. THE ALARM WAS CURRENTLY MUTED, AND THE CLINIC PLANNED TO DISCUSS AN EXCHANGE. 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 23696738 ↗
• MalfunctionDec 1, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM, AND DEPLETION OF THE INTERNAL BATTERY. THE CONTROLLER FAULT ALARM WAS PERMANENTLY MUTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681400 ↗
• MalfunctionNov 20, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO DEPLETED INTERNAL BATTERY. THE CONTROLLER WAS INITIALLY SILENCED BUT WAS SUBSEQUENTLY EXCHANGED SEVERAL DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610269 ↗

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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-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
• Z-2188-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1103

…and 44 more.