HeartWare® Battery 1650DE (UDI 00888707006873)Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 00888707006873), received between Jan 8, 2020 and Jun 6, 2023 — classified as 1 injury, 158 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (141 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. Jun 28, 2022Open, Classified

   Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.

   Z-1512-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY HAD 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 17071597 ↗
• MalfunctionMar 2, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE NOT WORKING. IT WAS NOTED THAT THE COMPLAINT FROM THE PATIENT WAS UNCLEAR, THOUGH IT APPEARED THE BATTERIES WERE NOT CHARGING. 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 16472431 ↗
• MalfunctionFeb 15, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WOULD NOT CHARGE. BOTH BATTERIES RESULTED IN YELLOW INDICATORS ON THE BATTERY CHARGER REGARDLESS OF HOW LONG THEY WERE PLUGGED IN REGARDLESS OF WHICH SLOT THEY WERE PLUGGED INTO. 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 16381895 ↗
• MalfunctionNov 17, 2022Battery Problem; Battery Problem

  A BATTERY WAS RETURNED TO THE MANUFACTURER AND 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 15815109 ↗
• MalfunctionNov 4, 2022Battery 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 15735925 ↗
• MalfunctionNov 2, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT AFTER ROUTINE LOG FILE REVIEW, IT WAS INDICATED 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 15714953 ↗
• MalfunctionOct 31, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THREE BATTERIES EXHIBITED POWER SWITCHING, THE PATIENT NOTED THE BATTERIES BEEPING AND DISCONNECTING. THE 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 15703244 ↗
• MalfunctionOct 13, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A POWER DISCONNECT 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 15597603 ↗
• MalfunctionAug 10, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS CHARGING BUT NOT BEING RECOGNIZED BY THE CONTROLLER. 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 15202236 ↗
• MalfunctionAug 4, 2022Battery Problem; Battery Problem

  IT WAS REPORTED BY THE MANUFACTURER THAT WHILE REVIEWING LOG FILE DATA FOR A PRIOR EVENT, THE DATA REVEALED 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 15165879 ↗
• MalfunctionJul 29, 2022Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT THAT ONE BATTERY WAS NO LONGER CHARGING TO FULL WHEN BEING CONNECTED TO THE BATTERY CHARGER OVER LONG PERIODS OF TIME. 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 15130118 ↗
• MalfunctionJun 30, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED POWER SWITCHING. THE BATTERY WAS TAKEN OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880052 ↗
• MalfunctionJun 28, 2022Battery Problem; Battery Problem

  IT WAS REPORTED BY THE MANUFACTURER THAT WHILE REVIEWING LOG FILE DATA FOR A PRIOR EVENT, THE DATA REVEALED COMMUNICATION ERRORS ON THE BATTERIES. 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 14841523 ↗
• MalfunctionJun 27, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A POOR MECHANICAL CONNECTION. THE PATIENT STATED THAT THE BATTERY WAS UNABLE TO MAINTAIN A SECURE CONNECTION TO THE CONTROLLER DUE TO THE SPRING NOT WORKING ON THE PORT OF THE BATTERY. 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 14827857 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BATTERY PIN WAS BROKEN OFF OF THE BATTERY. THE BATTERY WAS NO LONGER USEABLE. 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 14807799 ↗
• MalfunctionJun 17, 2022Battery Problem; Connection Problem; Battery Problem; Connection Problem

  IT WAS REPORTED THAT SIX BATTERIES HAD A POOR MECHANICAL CONNECTION THAT WERE UNABLE TO BE SECURED. IT WAS ALSO REPORTED THAT ONE OF THOSE BATTERIES ALSO HAD A CRITICAL BATTERY ALARM WHEN THE BATTERY CAPACITY WAS AT 85 PERCENT. IT WAS ALSO REPORTED THAT ANOTHER BATTERY HAD COMMUNICATION ERRORS AND POWER DISCONNECT ALARMS. SIX OF THE BATTERIES WERE REMOVED FROM SERVICE AND ONE 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 14733784 ↗
• MalfunctionJun 6, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THERE WAS AN ERRONEOUS 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 14605609 ↗
• MalfunctionJun 3, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A CRITICAL BATTERY ALARM WHEN THE BATTERY WAS REGISTERING A 67% CHARGE. 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 14594102 ↗
• MalfunctionMay 31, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT RECOGNIZED BY THE CONTROLLER AND NOT PROVIDING POWER. 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 14548603 ↗
• MalfunctionMay 27, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE "BRAND NEW" BATTERY HAD BEEN CHARGING FOR TWENTY-FOUR HOURS AND THE BATTERY CAPACITY DISPLAY ONLY SHOWED THREE BARS. IT WAS FURTHER REPORTED THAT THE BATTERY "FLASHED REDDISH ORANGE WHEN IT WAS PLUGGED IN." 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 14522304 ↗
• MalfunctionMay 12, 2022Battery 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 14374564 ↗
• MalfunctionApr 28, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING EVEN AFTER THE BATTERY HAD BEEN ON THE CHARGER OVERNIGHT. IT WAS THEN OBSERVED IN CLINIC THAT WHEN THE BATTERY WAS PLACED ON THE CHARGER, THE YELLOW LIGHT WOULD BLINK AND CONTINUED THROUGHOUT THE VISIT FOR APPROXIMATELY ONE HOUR. AT THE END OF THE VISIT, THE BATTERY SHOWED NO CHARGE. 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 14239138 ↗
• MalfunctionApr 28, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT CHARGE. THE BATTERY WAS ASSESSED IN CLINIC AND WAS PLACED ON THE BATTERY CHARGER BUT IT CO NTINUED TO BLINK YELLOW LIGHT FOR THE DURATION OF THE CLINIC VISIT. THE BATTERY SHOWED NO CHARGE AT THE END OF THE VISIT. IT WAS STATED THAT THE BATTERY DOES NOT REGISTER ANY CHARGE EVEN AFTER BEING LEFT ON THE CHARGER OVERNIGHT. 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 14238642 ↗
• MalfunctionMar 17, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE NOT PROVIDING POWER. PATIENT STATED NOT HEARING ANY ¿LOUD ALARMS¿ JUST THE BEEPING AS IF THE BATTERIES WERE DISCONNECTED. PATIENT ALSO STATED WHEN BATTERIES ARE CONNECTED TO THE CONTROLLER THE BATTERY GAUGES ARE BLACK AND AN ALARM FROM THE CONTROLLER INDICATING TO CONNECT A BATTERY. WHEN THE VENTRICULAR ASSIST DEVICE COORDINATOR REVIEWED THE ALARM HISTORY ALL WAS LISTED WAS A VAD STOPPED. 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 13794161 ↗
• MalfunctionMar 16, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS ABLE TO CHARGE BUT DID NOT REGISTER ANY LIGHTS WHEN CONNECTED TO THE CONTROLLER. 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 13780307 ↗

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-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-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-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-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
• Z-2190-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Implant Kit, REF 1125

…and 44 more.