HeartWare® Controller DC Adapter 1440 (UDI 00888707000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888707000260), received between Dec 21, 2017 and May 17, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Power Problem” (7 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC AND AC ADAPTERS WERE POWER SWITCHING. THE ADAPTERS WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8622020 ↗
• MalfunctionAug 22, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTOR WAS DAMAGED WITH EXPOSED WIRES. THE CONTROLLER DC ADAPTOR WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7805297 ↗
• MalfunctionAug 6, 2018Display or Visual Feedback Problem; Connection Problem; Power Problem

  IT WAS REPORTED THAT SINCE THE VENTRICULAR ASSIST DEVICE (VAD) POWER CONNECTIONS WERE ¿PAINTED¿, THE CONTROLLER DC ADAPTER WILL GET A POWER DISCONNECT ALARM AFTER INITIALLY WORKING FINE. THE CONTROLLER DC ADAPTER WOULD STATE THERE WAS NO POWER CONNECTED ON THE SIDE THE ADAPTER WAS PLUGGED INTO. THE CONTROLLER ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754966 ↗
• MalfunctionJun 20, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE DC ADAPTER WAS NOT BEING RECOGNIZED BY THE CONTROLLER AND THUS WAS NOT PROVIDING POWER. THE ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621019 ↗
• MalfunctionMay 1, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476508 ↗
• MalfunctionMar 6, 2018Loose or Intermittent Connection; Power Problem; Loose or Intermittent Connection; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER PROVIDED INTERMITTENT ELECTRICAL CONNECTION WHILE PLUGGED IN, WITH THE PLUG LIGHT INDICATOR FLASHING INTERMITTENTLY. WHILE THE CONTROLLER DC ADAPTER WAS IN-USE, THE PATIENT ALSO DISCONNECTED A LOW-POWER BATTERY AND WAS PREPARING TO CONNECT A FULLY-CHARGED BATTERY, BUT THE PUMP HAD A LOSS OF EXTERNAL POWER AND STOPPED, AT WHICH TIME THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS. THE SYMPTOMS RESOLVED AS SOON AS A FULLY-CHARGED BATTERY WAS CONNECTED TO THE CONTROLLER AND THE PUMP RE-STARTED. THE CONTROLLER DC ADAPTER WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 7316354 ↗
• MalfunctionJan 23, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER. THE ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214212 ↗
• MalfunctionDec 21, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DID NOT PROVIDE POWER TO THE CONTROLLER. THE DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139261 ↗

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-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-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-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-2197-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Accessories, REF MCS1753AK

…and 44 more.