HeartWare® Battery 1650DE (UDI 00888707005708)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 a heart pump used to support failing hearts. Nearly all of its 487 reports describe battery problems, many involving batteries that would not charge. Most patients had no clinical signs, and the reports include 1 injury and no deaths. One open recall from June 2022 covers battery faults that can stop it from charging or powering the controller. Reports fell from 27 the year before to none in the latest year.
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
- 487
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 487 adverse event reports that list this exact device (DI 00888707005708), received between Dec 6, 2018 and Jun 25, 2025 — classified as 1 injury, 486 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (445 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 Problem445
- Material Integrity Problem23
- Connection Problem17
- Break2
- Display or Visual Feedback Problem2
- Power Problem2
- Complete Loss of Power1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions362
- No Known Impact Or Consequence To Patient90
- No Consequences Or Impact To Patient61
- No Patient Involvement4
- Anxiety2
- Discomfort1
Recent adverse event reports
The 25 most recent of 487 reports, in the reporter's own words as published by the FDA.
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 22330475 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 22330473 ↗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 22330466 ↗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 22330461 ↗MalfunctionJun 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT LEDS ON THE BATTERY WERE NOT WORKING AS INTENDED. 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 22330459 ↗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 22330458 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT WHEN THE BATTERY WAS CONNECTED TO THE BATTERY CHARGER, THE INDICATOR LIGHT SHOWED A FLASHING RED LIGHT. ALL FOUR PORTS OF THE BATTERY CHARGER WERE TRIED, AND THERE WAS ALWAYS A FLASHING RED LIGHT. THE BATTERY WAS LEFT CONNECTED, BUT THE BATTERY NEVER CHARGED. THE BATTERY WILL BE 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 22330457 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY DID NOT CHARGE AS INTENDED ON ANY PORT OF THE BATTERY CHARGER. THE BATTERY WAS PLACED ON CHARGER OVERNIGHT, HOWEVER WAS NOT FULLY CHARGED. 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 22330456 ↗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 22330455 ↗MalfunctionJun 25, 2025Power Problem; Power Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED A RED LIGHT EMITTING DIODE ON THE BATTERY CHARGE CAPACITY DISPLAY. 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 22330452 ↗MalfunctionJun 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE LIGHT EMITTING DIODE (LED) ON THE BATTERY WAS NOT WORKING PROPERLY. 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 22330451 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE. 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 22330449 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND PROVIDED 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 22330448 ↗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 22330447 ↗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 22330446 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE AND A RED LIGHT WOULD DISPLAY ON THE 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 22330445 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED AN INABILITY TO CHARGE. 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 22330444 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND SHOWED A RED 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 22330443 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING ON ANY BATTERY CHARGER PORTS. THE PATIENT NOTED THE BATTERY WOULD APPEAR TO BE CHARGING WITH A YELLOW INDICATOR LIGHT BUT WOULD NOT CHARGE BEYOND ONE BAR ON THE POWER INDICATOR. 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 22330440 ↗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 22330439 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT, WHEN CONNECTED TO THE BATTERY CHARGER, THE BATTERIES WOULD NOT CHARGE AND ONE OF THE BATTERY CHARGER STATUS LIGHTS FLASHED RED. 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 22330438 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE "PAST TWO BARS ANYMORE" WHEN TESTED ON MULTIPLE CHARGER PORTS. THE BATTERY WAS EX CHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330434 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT WHEN THE BATTERY WAS CONNECTED TO THE BATTERY CHARGER THERE WAS A RED FLASHING INDICATOR 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 22330433 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WOULD NOT CHARGE ON ANY OF THE CHARGER PORTS AND IT DISPLAYED A RED LIGHT WHEN ATTACHED. 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 22330430 ↗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 22330429 ↗
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-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-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-1106-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- 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-1102-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
- 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-2188-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, REF 1103
- Z-2190-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Pump Implant Kit, REF 1125
…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.