HeartWare® Battery 1650DE (UDI 00888707005692)Recalls & reported problems
Heartware Inc. · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This HeartWare battery powers an implanted heart pump. Its 150 adverse event reports include 2 injuries and no deaths; most describe batteries that will not charge or show wrong battery status. The 1 recall, open and begun in June 2022, concerns battery faults that can stop the pump's controller from powering or charging. None were reported in the past 12 months, down from 10 before.
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
- 150
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00888707005692), received between May 30, 2019 and Jun 25, 2025 — classified as 2 injuries, 148 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (139 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.
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 · FDA record ↗
Most reported problems
Device problems
- Battery Problem139
- Material Integrity Problem9
- Connection Problem4
- Break1
- Device Alarm System1
- Display or Visual Feedback Problem1
- Material Deformation1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- No Known Impact Or Consequence To Patient47
- No Consequences Or Impact To Patient23
- No Patient Involvement1
- Syncope/Fainting1
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THERE WAS A BATTERY DISPLAY ERROR AND THE FOURTH INDICATOR LIGHT WAS NOT ILLUMINATING. 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 22330470 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED AN INABILITY TO CHARGE DESPITE ATTEMPTING ALL PORTS OF THE BATTERY CHARGER. THE BATTERY WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330468 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND DISPLAYED LIGHT EMITTING DIODE (LED) FLASHED RED AFTER CONNECTING TO 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 22330463 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 22330453 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 22330442 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED AN INABILITY TO CHARGE ASSOCIATED WITH A FLASHING RED BATTERY CHARGER STATUS LIGHT. 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 22330437 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY CHARGER EXHIBITED A FLASHING RED LIGHT WHEN THE BATTERY WAS CONNECTED. 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 22330423 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 22330422 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY HAD A FLASHING RED STATUS INDICATOR LIGHT WHEN CONNECTED TO 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 22330421 ↗MalfunctionApr 18, 2025Battery Problem; Connection Problem; Battery Problem; Connection Problem
THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED THAT THE BATTERY EXHIBITED MULTIPLE POWER DISCONNECT ALARMS. 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 21867965 ↗MalfunctionSep 18, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES HAD PROBLEM CHARGING WHEN PLUGGED INTO THE CHARGING STATION. 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 20248561 ↗MalfunctionOct 12, 2023Battery 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 17922096 ↗MalfunctionSep 13, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS CONNECTED PROPERLY TO THE CONTROLLER, BUT A POWER DISCONNECT ALARM STILL OCCURRED. THE BATTERY DID NOT PROVIDE POWER 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 17737458 ↗MalfunctionSep 12, 2023Battery Problem; Battery Problem
THREE BATTERIES WERE 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 17733296 ↗MalfunctionJul 10, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER. ALTHOUGH 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 17288859 ↗MalfunctionJun 30, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 17237029 ↗MalfunctionJun 23, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 17191069 ↗MalfunctionApr 10, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING AND POWER DISCONNECT ALARMS. IT WAS STATED THAT THE POWER DISCONNECT ALARMS OCCURRED WHEN THE BATTERIES WERE CHANGING BETWEEN EACH OTHER. IT WAS NOTED THAT NO POWER WAS DISCONNECTED WHEN THE ALARMS OCCURRED. 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 16708180 ↗MalfunctionFeb 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED POWER DISCONNECT ALARM AND DOES NOT PROVIDE POWER. IT WAS STATED THAT "EVEN THOUGH THE BATTERY WAS CONNECTED TO THE CONTROLLER PROPERLY, THE 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 16304386 ↗MalfunctionJan 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WOULD NOT 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 16112082 ↗MalfunctionDec 14, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT RECOGNIZED BY 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 15983037 ↗MalfunctionDec 1, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S BATTERY EXHIBITED AN APPROPRIATE CRITICAL BATTERY ALARM AND A POWER DISCONNECT. 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 15898315 ↗MalfunctionJul 12, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT TWO (2) BATTERIES WERE NOT CHARGING WHEN CONNECTED TO THE BATTERY CHARGER. 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 14988560 ↗MalfunctionMay 12, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER CONSUMPTION ISSUE AND WAS NOT CHARGING. THE BATTERY WAS BROKEN AS IT EXHIBITED FLASHING RED LIGHT WHEN THE BATTERY IS PLACED ON THE BATTERY CHARGER, BUT THE BATTERY DID NOT CHARGE. THE BATTERY REMAIN AT TWO GREEN LIGHT AND CONTINUED TO FLASH 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 14374732 ↗MalfunctionApr 25, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE FULLY CHARGED BATTERIES WERE DEPLETING SOONER THAN EXPECTED AND THAT THEY HAD A BATTERY CYCLE COUNT GREATER THAN 500. 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 14193854 ↗
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-1104-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- Z-1106-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Z-1102-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- Z-1105-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- 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-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-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-2189-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, REF 1104
- Z-2194-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Implant Kit, REF 1104JP
…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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.