HeartWare® Controller DC Adapter 1440 (REF A00153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888707006842), received between Feb 13, 2020 and May 12, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Power Problem” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Material Integrity Problem; Power Problem; Material Integrity Problem; Power Problem

  IT WAS REPORTED THAT THE END OF THE CONTROLLER DC ADAPTER THAT FITS INTO THE CAR OUTLET WAS BROKEN OFF AND NO LONGER PROVIDED POWER. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380174 ↗
• MalfunctionAug 25, 2021Connection Problem; Power Problem; Connection Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER CDC ADAPTER WAS NOT PROVIDING POWER DUE TO THE MIDDLE PIN OF THE CHARGING CONNECTOR BROKE AND FELL OUT. THE ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366045 ↗
• MalfunctionJun 30, 2021Power Problem; Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094683 ↗
• MalfunctionApr 6, 2021Mechanical Problem; Connection Problem; Power Problem; Mechanical Problem; Connection Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER DC ADAPTER WAS LOOSE AT THE CONNECTION WHERE IT PLUGS INTO THE CAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619995 ↗
• MalfunctionNov 23, 2020Power Problem; Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886450 ↗
• MalfunctionOct 13, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER CAME OUT OF THE BOX WITHOUT THE SILVER PIN THAT ALLOWS FOR CONNECTING TO THE CAR PORT. THE CONTROLLER DC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10671486 ↗
• MalfunctionFeb 13, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER TO THE CONTROLLER. THE CONTROLLER DC 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 9705931 ↗

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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• 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-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-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 45 more.