HeartWare® Battery 1650DE (UDI 00888707009942)Recalls & reported problems
Heartware Inc. · Class 3 · Implant
All models of HeartWare Battery (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This HeartWare 1650DE battery, used with a heart pump, has 109 malfunction reports, with no deaths and no injuries. Most reports describe battery problems such as communication errors, power disconnect alarms, or batteries that would not charge, and no patient complications are reported. 1 recall is open, started in June 2022, over battery electrical faults that can stop the battery from powering the controller or charging.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 109
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00888707009942), received between Oct 31, 2022 and Jun 6, 2024 — classified as 109 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (101 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.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Battery Problem101
- Connection Problem3
- Display or Visual Feedback Problem2
- Material Integrity Problem2
- Material Twisted/Bent2
- Electrical /Electronic Property Problem1
- Failure to Charge1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions109
Recent adverse event reports
The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT DURING ROUTINE LOG FILE REVIEW THE BATTERY EXHIBITED A POWER DISCONNECT ALARM. THE BATTERY REMAIN IN USE. NO P ATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19477413 ↗MalfunctionMay 3, 2024Battery Problem; Battery Problem
THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED A BATTERY 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 19238933 ↗MalfunctionMar 21, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT AFTER ROUTINE LOG FILE REVIEW, THE BATTERIES EXHIBITED COMMUNICATION ERRORS. 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 18951220 ↗MalfunctionMar 11, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT DURING ROUTINE LOG FILE REVIEW THE BATTERIES EXHIBITED A COMMUNICATION ERROR. 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 18876647 ↗MalfunctionFeb 27, 2024Battery Problem; Power Problem; Battery Problem; Power Problem
IT WAS REPORTED THAT A BATTERY EXHIBITED A POWER DISCONNECT ALARM OBSERVED IN LOG FILES. IT WAS ALSO REPORTED THAT THE PATIENT BROUGHT A BATTERY INTO THE CLINIC THAT HAD THE WORD "BAD" WRITTEN ON IT WITH A SHARPIE. THE BATTERIES WILL BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18789350 ↗MalfunctionJan 23, 2024Battery 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 18566369 ↗MalfunctionJan 12, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED A COMMUNICATION ERROR AND 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 18503483 ↗MalfunctionJan 4, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. PER THE PATIENT, THE BATTERY NEVER TURNED GREEN AFTER CHARGING EVEN AFTER 24HRS ON THE BATTERY CHARGER AND TRYING MULTIPLE CHARGING SLOTS. 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 18446356 ↗MalfunctionDec 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS. 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 18276868 ↗MalfunctionOct 17, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT BATTERY EXHIBITED A CRITICAL BATTERY ALARM WHILE THE CAPACITY WAS AT 39%, IT WAS ALSO NOTED THAT THERE WAS A COMMUNICATION ERROR. THE BATTERY IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17950006 ↗MalfunctionOct 11, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY SWITCHED AFTER TWO BARS INSTEAD OF GOING TO IT WAS REPORTED THAT THE PATIENT COMPLAINED THE BATTERY WOULD NOT FULLY DEPLETE WHEN CONNECTED TO THE CONTROLLER. IT WAS NOTED THAT THE BATTERY SWITCHED AFTER TWO BARS INSTEAD OF GOING TO THREE AS ANTICIPATED. 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 17916656 ↗MalfunctionOct 11, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY DISPLAYED A RED STATUS LIGHT WHEN PLACED ON THE CHARGER. IT WAS ALSO REPORTED THAT THE BATTERY WAS TESTED IN ALL BAYS. 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 17913136 ↗MalfunctionOct 11, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THAT THE PATIENT WENT TO THE DAY HOSPITAL. THE PATIENT STATED THAT THIS MORNING AT 6 AM TWO FULL BATTERIES WERE PUT IN BEFORE LEAVING HOME. THE PATIENT NOTICE AT 11AM THAT THESE TWO BATTERIES WERE EMPTY. 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 17912748 ↗MalfunctionOct 10, 2023Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem
IT WAS FURTHER REPORTED THAT THAT THE PATIENT WENT TO THE DAY HOSPITAL. THE PATIENT STATED THAT THIS MORNING AT 6 AM TWO FULL BATTERIES WERE PUT IN BEFORE LEAVING HOME. THE PATIENT NOTICE AT 11AM THAT THESE TWO BATTERIES WERE EMPTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17905742 ↗MalfunctionSep 29, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING INTERMITTENTLY, AS INDICATED BY A RED LIGHT. 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 17847906 ↗MalfunctionSep 18, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING IN ANY POCKET ON THE BATTERY CHARGER. 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 17770124 ↗MalfunctionSep 15, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THERE WERE ISSUES WITH MULTIPLE BATTERIES. THREE BATTERIES EXHIBITED POWER DISCONNECT ALARMS, AND ONE BATTERY EXHIBITED AN ERRONEOUS CRITICAL BATTERY ALARM. 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 17756458 ↗MalfunctionSep 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE BATTERY WAS RETURNED TO THE MANUFACTURER DUE TO A DISPLAY ERROR. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17746028 ↗MalfunctionSep 12, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING. 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 17732125 ↗MalfunctionSep 12, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING. 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 17731615 ↗MalfunctionSep 7, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND NOT HOLDING A 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 17700533 ↗MalfunctionSep 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING, WHEN THE BATTERY WAS PLACED ON THE CHARGER IT DISPLAYED A SOLID RED LIGHT ON THE CHARGER. 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 17691309 ↗MalfunctionAug 31, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER DISCONNECT ALARMS, AND TWO OF THE BATTERIES ALSO EXHIBITED ERRONEOUS CRITICAL BATTERY ALARMS. 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 17661922 ↗MalfunctionAug 23, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND NOT HOLDING CHARGE. THE BATTERY WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17603056 ↗MalfunctionAug 23, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES DID NOT PROVIDE POWER. THE BATTERIES WERE FULLY CHARGED, BUT THE CONTROLLER DID NOT RECOGNIZE THE BATTERIES WHEN THE BATTERIES WERE CONNECTED TO THE CONTROLLER. IT WAS NOTED THAT THE BATTERIES' PINS WERE CLEAN AND UN-DAMAGED. 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 17603033 ↗
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, ClassifiedHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
- Z-1993-2023 · May 16, 2023 · Open, ClassifiedHeartWare 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, ClassifiedHeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
- Z-1207-2022 · Apr 14, 2022 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
- Z-1102-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- Z-1106-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Z-1107-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) H
- Z-1110-2022 · Mar 30, 2022 · Open, ClassifiedInstructions 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, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Z-1104-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- Z-1105-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- Z-0726-2022 · Jan 27, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System
- Z-2478-2021 · Aug 6, 2021 · Open, ClassifiedMedtronic HVAD Pump Implant Kits
- Z-2190-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, REF 1125
- Z-2189-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, REF 1104
…and 44 more.
Other Ventricular (Assist) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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