HeartWare® Controller DC Adapter 1440 (UDI 00888707002745)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888707002745), received between May 1, 2018 and Jan 11, 2023 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Power Problem” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER CABLE WAS DAMAGED. THE CONNECTION PART OF THE CABLE WAS TORN BY THE PATIENT'S MISTAKE. THE CONTROLLER DC ADAPTER WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140972 ↗
• MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER CABLE WAS DAMAGED. A PART OF THE CABLE WAS TORN SLIGHTLY 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 16140792 ↗
• MalfunctionJan 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CDC ADAPTER EXHIBITED A DAMAGED CABLE. THE PLASTIC PART OF THE CONNECTION WAS SLIGHTLY BROKEN BY THE PATIENT. 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 16139192 ↗
• MalfunctionDec 15, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC (CDC) ADAPTER WAS DAMAGED, A PART OF THE CABLE WAS TORN ACCIDENTALLY BY THE PATIENT. THE CDC CABLE WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986645 ↗
• MalfunctionMay 18, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT CONTROLLER DC (CDC) ADAPTER CABLE WAS BROKEN. 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 14429884 ↗
• MalfunctionMar 9, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CDC ADAPTER FELL FROM THE PATIENT'S HAND AND THE ADAPTER CABLE WAS DAMAGED. THE 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 11445793 ↗
• MalfunctionOct 27, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CDC ADAPTER WAS BROKEN. THE CDC ADAPTER WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10741727 ↗
• MalfunctionSep 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER WAS DAMAGED. THE PATIENT CLOSED THE CAR DOOR ON THE CABLE AND IT BROKE. THE DC ADAPTER WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515625 ↗
• MalfunctionAug 24, 2020Power Problem; Power Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10444484 ↗
• MalfunctionMar 25, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT CONTROLLER DC ADAPTER DID NOT PROVIDE 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 8449427 ↗
• MalfunctionDec 21, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC ADAPTER EMITTED A BEEP AND STOPPED PROVIDING POWER TO THE CONTROLLER. THE 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 8191002 ↗
• MalfunctionNov 19, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DID NOT PROVIDE POWER AND DID NOT DISPLAY A GREEN LIGHT WHEN PLUGGED INTO THE CAR. THE PRODUCT WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085249 ↗
• MalfunctionNov 6, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT A PATIENT'S CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER. THE EVENT WAS NOT ASSOCIATED WITH ANY CONTROLLER ALARMS OR PUMP STOP EVENTS. THE CONTROLLER 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 8043206 ↗
• MalfunctionSep 28, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DC ADAPTER CABLE WAS DAMAGED ON THE SIDE OF THE CABLE THAT CONNECTS TO THE PATIENT'S CONTROLLER. THE PATIENT STATED HE ACCIDENTALLY SLAMMED THE CABLE IN THE CAR DOOR. THE 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 7919504 ↗
• MalfunctionSep 7, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTOR DID NOT PROVIDE POWER TO THE CONTROLLER. THE 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 7856205 ↗
• MalfunctionAug 29, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER DC ADAPTER WAS NOT PROVIDING POWER. THERE WERE NO PUMP STOPS OR CONTROLLER ALARMS ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826966 ↗
• MalfunctionAug 6, 2018Disconnection; Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTOR WOULD NOT STAY PLUGGED INTO CAR OUTLET. 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 7754148 ↗
• MalfunctionJun 4, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER DOES NOT PROVIDE POWER. THE GREEN LIGHT ON THE ADAPTER DOES NOT LIGHT UP. 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 7565572 ↗
• MalfunctionMay 1, 2018Connection Problem; Device Operates Differently Than Expected; Power Problem; Connection Problem; Device Operates Differently Than Expected; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER DC ADAPTER MALFUNCTIONED. 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 7476432 ↗

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-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-1106-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
• 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-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-2192-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Driveline Extension Cable, REF 100

…and 44 more.