HeartWare® Controller DC Adapter 1440 (UDI 00888707006880)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888707006880), received between Dec 2, 2021 and Sep 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER DC (CDC) ADAPTER WAS DAMAGED, THE FRONT PART WAS SEPARATED. THE CDC 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 17683828 ↗
• MalfunctionDec 15, 2022Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PART OF THE CONTROLLER DC ADAPTER CABLE WAS TORN BY THE PATIENT'S MISTAKE. 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 15987004 ↗
• MalfunctionDec 2, 2021Misassembled; Use of Device Problem; Misassembled; Use of Device Problem

  THE CONTROLLER DC ADAPTER WAS RETURNED TO THE MANUFACTURER BECAUSE IT WAS UNASSEMBLED WHEN THE BOX WAS OPENED. THE CONTROLLER DC ADAPTER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920653 ↗

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-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-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• 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-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• 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 45 more.