HeartWare® Battery 1650DE (UDI 00888707002646)Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00888707002646), received between Jun 25, 2018 and Feb 7, 2023 — classified as 130 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (119 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 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Battery Problem; Battery Problem

  IT WAS REPORTED BY THE MANUFACTURER THAT WHILE REVIEWING LOG FILE DATA FOR A PRIOR EVENT, THE DATA REVEALED THAT THE BATTERY EXHIBITED A CRITICAL BATTERY ALARM DUE TO 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 16312183 ↗
• MalfunctionMay 19, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING. THE BATTERIES WOULD CHARGE OVERNIGHT AND THEN WOULD DIE WITHIN FIVE MINUTES OF BEING USED. THE BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436516 ↗
• MalfunctionApr 13, 2022Battery Problem; Battery Problem

  IT WAS REPORTED BY THE MANUFACTURER THAT WHILE REVIEWING LOG FILE DATA FOR A PRIOR EVENT, THE DATA REVEALED A CRITICAL BATTERY ALARM. 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 14106375 ↗
• MalfunctionSep 23, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS FAULTY AS IT DID NOT PROVIDE POWER. THE BATTERY WOULD SHOW FULLY CHARGED BUT DOES NOT PROVIDE POWER. 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 12519627 ↗
• MalfunctionAug 6, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A CRITICAL BATTERY ALARM. 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 12289352 ↗
• MalfunctionAug 3, 2021Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE CONTROLLER HAD AN UNEXPECTED LOSS OF POWER. THE CONTROLLER REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267469 ↗
• MalfunctionJun 17, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES AND BATTERY CHARGER WERE NOT CHARGING. IT WAS ALSO REPORTED THAT SOME OF THE BATTERIES WOULD NOT REGISTER POWER ON THE CONTROLLER AND TWO BATTERIES EXHIBITED COMMUNICATION ERRORS ASSOCIATED WITH POWER DISCONNECT ALARMS. THE BATT ERIES AND BATTERY CHARGER WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022085 ↗
• MalfunctionMar 30, 2021Battery Problem; Battery Problem

  IT WAS ALSO REPORTED THAT ANOTHER BATTERY EXHIBITED COMMUNICATION ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588559 ↗
• MalfunctionMar 29, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED AN ERRONEOUS CRITICAL BATTERY ALARM. THE BATTERY CHARGE WAS 94% AT THE TIME OF THE 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 11586897 ↗
• MalfunctionMar 11, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES SHOWED A CHARGE OF GREATER THAN 100 PERCENT ON LOG FILES, AND ONE OF THE BATTERIES HAD BEHAVIOR SIMILAR TO POWER SWITCHING. 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 11466528 ↗
• MalfunctionFeb 8, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT ONE OF THE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS, THOUGH IT COULD NOT BE DETERMINED WHICH SPECIFIC BATTERY EXHIBITED THE ALARMS. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297721 ↗
• MalfunctionDec 13, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED AN INABILITY TO CHARGE. 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 10998159 ↗
• MalfunctionNov 17, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED AN ERRONEOUS CRITICAL BATTERY ALARM. THE BATTERY CHARGE WAS 63% AT THE TIME OF THE ALARM. MULTIPLE POWER DISCONNECT ALARMS WERE ALSO NOTED. 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 10856846 ↗
• MalfunctionOct 1, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING, INTERMITTENT BEEPING, AND AN INABILITY TO HOLD A CHARGE. THE BATTERIES WERE EXCHANGED. 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 10613120 ↗
• MalfunctionAug 17, 2020Battery Problem; Battery Problem

  FOUR ADDITIONAL BATTERIES AND A CONTROLLER AC ADAPTER WERE RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413512 ↗
• MalfunctionJul 30, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE GIVING CRITICAL BATTERY ALARMS AND EXHIBITING COMMUNICATION ERROR. THE BATTERIES REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347534 ↗
• MalfunctionJun 10, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS GIVING AN ERRONEOUS CRITICAL BATTERY ALARM. THE BATTERY HAD A CHARGE CAPACITY OF 75% AT THE TIME OF THE ALARM. THE BATTERY WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140778 ↗
• MalfunctionMay 12, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A BEEP WHEN ATTACHED TO THE CONTROLLER AND DISPLAYED AS FULLY CHARGED. IT WAS STATED THAT IT WAS POSSIBLE THAT THERE WAS A POSSIBLE CONTACT ISSUE WITH THE CONNECTION OF THE BATTERY, THE BATTERY WAS PREVIOUSLY LUBRICATED PROPHYLACTICALLY. THE BATTERY 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 10048309 ↗
• MalfunctionMay 8, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING AND THE PATIENT HEARD TWICE UNUSUAL ALARM SOUND. THE FIRST ALARM HAPPENED WHEN TWO BATTERIES WERE CONNECTED AND THE SECOND ALARM HAPPENED WHEN THE BATTERY AND CONTROLLER AC ADAPTER WERE CONNECTED. THE BATTERIES 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 10040786 ↗
• MalfunctionApr 17, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT TWO BATTERIES DID NOT PROVIDE POWER AND WOULD NOT HOLD A CHARGE. THE BATTERIES 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 9972675 ↗
• MalfunctionMar 17, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT TWO BATTERIES EXHIBITED POWER SWITCHING AND THERE WAS A PUMP STOP DUE TO LOSS OF POWER TO THE CONTROLLER. THE BATTERIES 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 9843343 ↗
• MalfunctionFeb 12, 2020Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS REPORTED THAT THREE BATTERIES WERE POWER SWITCHING. IT WAS ALSO NOTED THAT THE BATTERIES WERE DISCHARGING MUCH FASTER THAN IN THE PAST. THE BATTERIES WERE PROPHYLACTICALLY TREATED WITH LUBRICATION AT IMPLANT. THE BATTERIES WERE REMOVED FROM SERVICE AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700462 ↗
• MalfunctionJan 9, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE POWER SWITCHING MULTIPLE TIMES WHEN HOOKED UP TO THE CONTROLLER ALONG WITH SINGLE BEEPS. THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9571860 ↗
• MalfunctionJan 2, 2020Battery Problem; Battery Problem

  THE BATTERY WAS RETURNED TO MANUFACTURER BECAUSE THE BATTERY WAS NOT CHARGING. THE BATTERY SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9540478 ↗
• MalfunctionDec 18, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS POWER SWITCHING. THE BATTERY 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 9490588 ↗

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-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-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• 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-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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 44 more.