HeartWare® Battery 1650DE (UDI 00763000629717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00763000629717), received between Sep 11, 2023 and Sep 30, 2026 — classified as 109 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (104 reports).

60 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952743 ↗
• MalfunctionSep 3, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598076 ↗
• MalfunctionAug 11, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210715 ↗
• MalfunctionDec 23, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT FIVE (5) BATTERIES EXHIBITED AN IRREGULARITY IN WHICH, WHEN A BATTERY WAS LESS THAN 25% THE CONTROLLER SWITCHED TO THE OTHER POWER SOURCE, THE LOW CAPACITY BATTERY THEN RECOVERED ONE LED MORE, SHOWING A TOTAL OF TWO. THIS WAS REPORTED AS AN IRREGULARITY BY THE PATIENT AND HAD NOT BEEN PREVIOUSLY OBSERVED. 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 23878134 ↗
• MalfunctionDec 1, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING WHILE IN THE PATIENT'S OWNERSHIP. THE BATTERY WAS REPLACED. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681852 ↗
• MalfunctionNov 17, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PIONEER BATTERY FLASHED RED, EVEN WHEN CHANGING THE CHARGING SLOT. 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 23572598 ↗
• MalfunctionNov 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS BLINKING RED WHEN ATTEMPTING TO CHARGE AND NOT CHARGING. THE BATTERY WAS REMOVED FROM USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453735 ↗
• MalfunctionOct 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT BATTERY EXHIBITED AN ISSUE WHERE THE BATTERY WAS FLASHING RED WHEN ON THE CHARGER, WHILE ANOTHER BATTERY WERE CHARGING IN A DIFFERENT SLOT BEHAVED NORMAL. 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 23404569 ↗
• MalfunctionOct 27, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PIONEER BATTERIES EXHIBITED DECREASED BATTERY OPERATING TIME, WITH THE BATTERY LASTING LESS THAN ONE HOUR PER BAR. AT THE LOGFILE FOLLOW-UP, IT WAS CONFIRMED THAT THE BATTERIES HAD 300 CYCLES. 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 23394433 ↗
• MalfunctionSep 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING. WHEN THE BATTERIES WERE PLACED ON THE BATTERY CHARGER THEY WERE FLASHING RED. 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 22977930 ↗
• MalfunctionSep 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED AN ERRONEOUS CRITICAL BATTERY ALARM. 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 22977641 ↗
• MalfunctionAug 27, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE CLINIC WITH CONCERNS REGARDING PIONEER BATTERIES, SPECIFICALLY THAT FOUR BATTERIES WERE NOT CHARGING PAST TWO BARS OR 50%. THE PATIENT HAD PREVIOUSLY REPORTED SIMILAR ISSUES WITH TWO BATTERIES ABOUT A MONTH PRIOR AND HAD RECEIVED TWO NEW BATTERIES AT THAT TIME. DURING THE CLINIC VISIT, THE PATIENT REPORTED THAT THE SAME TWO BATTERIES, ALONG WITH TWO ADDITIONAL BATTERIES, WERE NOT CHARGING FULLY. THE PATIENT STILL HAS FOUR OTHER BATTERIES AT HOME THAT ARE FUNCTIONING PROPERLY, AND IT WAS NOTED THAT THE BATTERY CHARGER WAS LIKELY NOT THE SOURCE OF THE ISSUE SINCE THE OTHER BATTERIES WERE CHARGING AS EXPECTED. ONE OF THE AFFECTED BATTERIES WAS NEWLY PROVIDED ON (B)(6) 2025. 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 22904569 ↗
• MalfunctionAug 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT TWO PIONEER BATTERIES WERE CONNECTED AND DID NOT PROVIDE POWER TO THE CONTROLLER, AND THE BATTERY INDICATOR DID NOT ILLUMINATE ON THE CONTROLLER. THERE WERE NO CONTROLLER ALARMS OR PUMP STOP EVENTS ASSOCIATED WITH THIS OCCURRENCE. 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 22894615 ↗
• MalfunctionAug 22, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT PIONEER BATTERIES WERE ASSOCIATED WITH POWER SWITCHING ISSUES WHILE IN THE PATIENT'S OWNERSHIP AND CONNECTED MEDIUM TO LONG TERM. THE BATTERIES WERE EXCHANGED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873708 ↗
• MalfunctionAug 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A REVIEW OF LOG FILE DATA REVEALED THE BATTERIES EXHIBITED A COMMUNICATION ERROR. THE BATTERIES 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 22796044 ↗
• MalfunctionAug 8, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND WAS 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 22749872 ↗
• MalfunctionJul 31, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PIONEER BATTERIES WERE NOT CHARGING WHILE IN THE PATIENT'S OWNERSHIP AND CONNECTED MEDIUM TO LONG TERM. THE AFFECTED 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 22676958 ↗
• MalfunctionJul 22, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A POWER DISCONNECT ALARM ASSOCIATED WITH A COMMUNICATION ERROR. 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 22566370 ↗
• MalfunctionJul 21, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY HAD POWER SWITCHING AND A POWER DISCONNECT ALARM. THE VENTRICULAR ASSIST DEVICE (VAD) NEVER STOPPED. 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 22555895 ↗
• MalfunctionJul 17, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED ERRONEOUS CRITICAL BATTERY ALARMS AND THAT THE CONTROLLER WAS INTERMITTENTLY BEEPING WITH POWER DISCONNECT ALARMS ON PORT TWO DESPITE THE BATTERY BEING FULLY CHARGED. INITIALLY THE PATIENT WAS UNABLE TO IDENTIFY WHICH BATTERY WAS CAUSING THE ALARM, THOUGH IT WAS HAPPENING ON PORT TWO OF THE CONTROLLER. THE FOLLOWING MORNING THE CONTROLLER ALARMED AGAIN WITH A CRITICAL BATTERY ALARM AND THE BATTERY WAS THE SAME AS THE PREVIOUS NIGHT. LOG FILE REVIEW REVEALED THAT THE BATTERY EXHIBITED A COMMUNICATION ERROR. THE BATTERY WAS REPLACED, AND ANOTHER POWER DISCONNECT ALARM OCCURRED ON PORT TWO OF THE CONTROLLER. THE SECOND BATTERY WAS REPLACED. IT WAS STATED THAT THERE WAS NO DUST/DEBRIS OR OTHER DAMAGE ON THE CONTROLLER. THE HEALTHCARE PROFESSIONAL SAID THEY THEN BLEW ON THE PORT AND IT FIXED THE PROBLEM. 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 22531823 ↗
• MalfunctionJul 16, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A REVIEW OF LOG FILES DATA REVEALED SEVERAL BATTERIES EXHIBITED POWER DISCONNECT ALARMS. 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 22522422 ↗
• MalfunctionJul 2, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF POWER DISCONNECT ALARMS AND ERRONEOUS CRITICAL BATTERY ALARMS WHILE USING THEIR CONTROLLER. UPON REVIEWING THE LOG FILES, IT WAS DISCOVERED THAT SEVERAL BATTERIES THAT SHOULD NOT HAVE BEEN IN USE WERE USED. THE SITE REPLACED TWO OF THE BATTERIES WITH NEW ONES, AND THE FOUR REMAINING BATTERIES WERE PROMPTLY REMOVED AND PROPERLY DISPOSED OF. IT WAS ALSO DECIDED NOT TO CHANGE THE CONTROLLER AT THIS TIME UNLESS FURTHER ISSUES ARISE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383180 ↗
• MalfunctionJun 24, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER NOR IS IT CHARGING. THE STATUS LIGHT OF THE BATTERY CHARGER IS RED WHEN THE BATTERY IS 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 22320830 ↗
• MalfunctionJun 24, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT PROVIDE POWER OR CHARGE. THE STATUS LIGHT OF THE BATTERY CHARGER IS RED WHEN THE BATTERY IS 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 22320484 ↗
• MalfunctionJun 17, 2025Battery Problem; Pumping Problem; Battery Problem; Pumping Problem

  IT WAS REPORTED THAT ROUTINE REVIEW OF LOG FILES DATA REVEALED THAT THREE BATTERIES EXHIBITED COMMUNICATION ERRORS AND CRITICAL BATTERY ALARMS DESPITE HAVING A CHARGE CAPACITY GREATER THAN 50%. IT WAS ALSO NOTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED A LOW FLOW ALARM. THE BATTERIES AND VAD 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 22237062 ↗

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-1512-2022 · Jun 28, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
• 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-1104-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
• 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-1103-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
• Z-1105-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
• Z-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-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-2196-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Outflow Graft, REF MCS1725OG

…and 45 more.