HeartWare® Battery 1650DE (UDI 00888707000369)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,126 adverse event reports that list this exact device (DI 00888707000369), received between Jan 12, 2016 and Jan 16, 2024 — classified as 5 injuries, 1,121 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1,040 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 25 most recent of 1,126 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Battery Problem; Battery Problem

  A BATTERY WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519143 ↗
• MalfunctionOct 17, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY HAS OVER 500 CYCLES AND IT IS DEPLETING ON A VERY SHORT TIME. THE BATTERY 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 17950845 ↗
• MalfunctionAug 24, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT A POWER DISCONNECT ALARM OCCURRED WHILE THE BATTERY WAS CONNECTED PROPERLY TO THE CONTROLLER. THE BATTERY 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 17612593 ↗
• MalfunctionAug 22, 2023Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE BATTERY WAS REMOVED FROM SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599351 ↗
• MalfunctionAug 17, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING. BOTH BATTERIES HAVE BEEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565449 ↗
• MalfunctionAug 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BATTERY HAD A BROKEN AND CRACKED CABLE. THE BATTERY WAS REMOVED FROM USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549380 ↗
• MalfunctionAug 10, 2023Battery Problem; Battery Problem

  I WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER, EVEN THOUGH IT WAS CONNECTED PROPERLY TO THE CONTROLLER A POWER DISCONNECT ALARM OCCURRED. THE BATTERY 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 17498505 ↗
• MalfunctionAug 1, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THREE BATTERIES DEPLETED VERY FAST. IT WAS NOTED THAT THE BATTERIES HAD OVER 500 CHARGE CYCLE COUNTS. THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434954 ↗
• MalfunctionJul 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED UNSPECIFIED DAMAGE. THE BATTERY WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305820 ↗
• MalfunctionJun 30, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER. ALTHOUGH THOUGH THE BATTERY WAS CONNECTED TO THE CONTROLLER PROPERLY A POWER DISCONNECT ALARM OCCURRED. THE BATTERY 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 17238357 ↗
• MalfunctionJun 13, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT PROVIDING POWER TO THE CONTROLLER AND THERE WAS A POWER DISCONNECT ALARM EVEN THOUGH THE BA TTERY WAS CONNECTED TO THE CONTROLLER PROPERLY. THE BATTERY 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 17116909 ↗
• MalfunctionJun 9, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS PROPERLY CONNECT TO THE CONTROLLER BUT DID NOT PROVIDE POWER RESULTING IN A POWER DISCONNECT ALARM OCCURRED. THE BATTERY 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 17098275 ↗
• MalfunctionJun 1, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A COMMUNICATION ERROR. THE BATTERY 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 17038435 ↗
• MalfunctionMay 23, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THE BATTERIES DID NOT PROVIDE POWER EVENT THOUGH THEY WERE PROPERLY CONNECTED TO THE CONTROLLER. IT WAS ALSO REPORTED THAT POWER DISCONNECT ALARMS OCCURRED. THE BATTERIES WERE DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986113 ↗
• MalfunctionMay 23, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT TWO BATTERIES EXHIBITED UNSPECIFIED DAMAGE. THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985555 ↗
• MalfunctionApr 25, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT FOUR (4) OF THE PATIENT BATTERIES WERE NOT SUPPORTING >3-4 HOURS OF CHARGE. THE BATTERIES WERE REMOVED FROM SER VICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807302 ↗
• MalfunctionApr 20, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER AND EXHIBITED A POWER DISCONNECT ALARM. THE BATTERY 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 16776890 ↗
• MalfunctionApr 3, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES DID NOT PROVIDE POWER AND EXHIBITED POWER DISCONNECT ALARMS WHILE CORRECTLY BEING ATTACHED TO THE CONTROLLER. THE BATTERIES WERE 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 16667268 ↗
• MalfunctionMar 9, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES DID NOT PROVIDE POWER ALTHOUGH THEY WERE CONNECTED PROPERLY TO THE CONTROLLER, POWER DISCONNECT ALARMS OCCURRED. THE BATTERIES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514140 ↗
• MalfunctionMar 8, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER. IT WAS ALSO REPORTED THAT THE BATTERY WAS PROPERLY CONNECTED TO THE CONTROLLER AND A POWER DISCONNECT ALARM OCCURRED. THE BATTERY WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504182 ↗
• MalfunctionMar 2, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A POWER DISCONNECT ALARM AND DID NOT PROVIDE POWER. IT WAS NOTED THAT THE BATTERY WAS CONNECTED TO THE CONTROLLER PROPERLY. THE BATTERY 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 16468578 ↗
• MalfunctionFeb 28, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THREE BATTERIES WERE EXHIBITING MULTIPLE ISSUES. THE THREE BATTERIES DID NOT PROVIDE POWER AND EXHIBITED MULTIPLE POWER DISCONNECT ALARMS, EVEN WHEN THE BATTERIES WERE PROPERLY CONNECTED TO THE CONTROLLER. THE BATTERIES WERE 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 16452826 ↗
• MalfunctionFeb 15, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER DISCONNECT ALARMS AND WERE NOT PROVIDING POWER WHEN PLUGGED INTO THE CONTROLLER. THE BATTERIES WERE 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 16381087 ↗
• MalfunctionFeb 13, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER TO THE CONTROLLER. EVEN THOUGH THE BATTERY WAS CONNECTED TO THE CONTROLLER PROPERLY, A POWER DISCONNECT ALARM OCCURRED. THE BATTERY 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 16363553 ↗
• MalfunctionFeb 10, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED POWER CONSUMPTION ISSUE AS IT LAST FOR LESS THAN TWO HOURS. THE BATTERY 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 16353670 ↗

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