HeartWare® Battery 1650DE (UDI 00888707006897)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 is a battery for a HeartWare ventricular assist device. The 615 reports all describe malfunctions, mostly the battery not charging, cutting out, or showing a warning light. There are no deaths and no injuries. There is 1 open recall, started in June 2022, for battery faults that can stop the battery 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
- 615
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 615 adverse event reports that list this exact device (DI 00888707006897), received between Sep 2, 2020 and Jun 25, 2025 — classified as 615 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (603 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 Problem603
- Connection Problem16
- Material Integrity Problem8
- Power Problem4
- Electrical /Electronic Property Problem3
- Break1
- Device Alarm System1
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions613
- No Consequences Or Impact To Patient15
- No Patient Involvement2
- Discomfort1
Recent adverse event reports
The 25 most recent of 615 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED A FLASHING RED LIGHT WHEN CONNECTED TO 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 22330478 ↗MalfunctionJun 25, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND EXHIBITED A RED INDICATOR LIGHT WHEN CONNECTED TO THE BATTERY 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 22330464 ↗MalfunctionJun 5, 2024Battery Problem; Battery Problem
THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. THE MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED A POWER DISCONNECT AND 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 19470884 ↗MalfunctionApr 25, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT DURING LOG FILE REVIEW IT WAS NOTICED THAT THE BATTERY EXHIBITED POWER DISCONNECTS. 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 19182591 ↗MalfunctionJan 18, 2024Battery Problem; Battery Problem
IT WAS FURTHER REPORTED THAT THE BATTERY WAS EXCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18533444 ↗MalfunctionDec 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED AN UNKNOWN MALFUNCTION. 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 18275264 ↗MalfunctionAug 16, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER AND EXHIBITED A POWER DISCONNECT ALARM DESPITE BEING CONNECTED TO THE CONTROLLER. 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 17557358 ↗MalfunctionAug 16, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED A POWER CONSUMPTION ISSUE, ONLY DISCHARGES HALF WAY. 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 17557136 ↗MalfunctionJul 14, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT TWO BATTERIES DID NOT PROVIDE POWER AND A POWER DISCONNECT ALARM OCCURRED. A THIRD BATTERY HAD A CYCLE COUNT GREATER THAN 500 AND RUNS OUT FAST. 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 17326119 ↗MalfunctionJul 11, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE FULLY CHARGED BATTERIES DEPLETED "VERY FAST". IT WAS FURTHER REPORTED THAT THE BATTERIES HAD OVER 500 CYCLES. 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 17298884 ↗MalfunctionJul 6, 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 17270470 ↗MalfunctionJun 21, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT TWO (2) BATTERIES WERE NOT CHARGING. THE TWO 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 17172444 ↗MalfunctionJun 20, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING, NOT PROVIDED POWER AND 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 17164036 ↗MalfunctionMay 31, 2023Battery Problem; Battery Problem
IT WAS FURTHER REPORTED THAT THE BATTERY WAS EXCHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032058 ↗MalfunctionMay 22, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER AND WAS NOT RECOGNIZED BY THE CONTROLLER. 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 16979790 ↗MalfunctionMay 16, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT 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 16939409 ↗MalfunctionMay 5, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE FULLY CHARGED BATTERY WAS NOT RECOGNIZED BY THE CONTROLLER WHEN CONNECTED. 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 16876130 ↗MalfunctionMay 1, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY EXHIBITED AN UNSPECIFIED ISSUE. 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 16843733 ↗MalfunctionApr 18, 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 16764210 ↗MalfunctionApr 3, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT PROVIDING 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 16668650 ↗MalfunctionMar 29, 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 16635221 ↗MalfunctionMar 9, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. THE BATTERY HAS BEEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16514148 ↗MalfunctionMar 3, 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 16477874 ↗MalfunctionMar 2, 2023Battery 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 16467816 ↗MalfunctionFeb 20, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 16404780 ↗
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-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-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-1106-2022 · Mar 30, 2022 · Open, ClassifiedHeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- 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-2192-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Driveline Extension Cable, REF 100
- Z-2193-2021 · Jun 3, 2021 · Open, ClassifiedHeartWare HVAD Driveline Extension Cable, REF 100US
…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.