HeartWare BatteryRecalls & reported problems across all models

We found 11 models of HeartWare Battery by Heartware Inc. in the FDA's device registry (GUDID). Together they are named in 4,241 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2016 and Sep 30, 2026 — classified as 16 injuries, 4,225 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (3,920 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HeartWare Battery recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 6 of these models · Recall details · FDA record ↗

2. May 5, 2022Open, Classified

   Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.

   Z-1266-2022 · Root cause: Process control · Recall details · FDA record ↗

3. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

   Z-1438-2021 · Root cause: Device Design · Recall details · FDA record ↗

4. Feb 26, 2021Open, Classified

   IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

   Z-1469-2021 · Root cause: Device Design · Recall details · FDA record ↗

5. May 2, 2018Open, Classified

   Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

   Z-1903-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported HeartWare Battery problems

HeartWare Battery models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartWare® Battery 1650DE

  Ventricular (Assisst) Bypass
  1 recall1,126 reports
• HeartWare® Battery 1650

  Ventricular (Assisst) Bypass
  3 recalls740 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  2 recalls606 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  1 recall615 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  1 recall487 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  1 recall159 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  1 recall150 reports
• HeartWare® Battery 1650DE

  Ventricular (Assisst) Bypass
  1 recall130 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  1 recall109 reports
• HeartWare® Battery 1650DE

  Ventricular (Assist) Bypass
  109 reports
• HeartWare® Battery 1650

  Ventricular (Assisst) Bypass
  10 reports

Recent HeartWare Battery adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Heartware Inc. products

• HVAD Pump Implant Kit5 models · 5,895 reports · 11 recalls
• HVAD Controller3 models · 2,990 reports · 5 recalls
• HeartWare Controller2 models · 2,393 reports · 3 recalls
• Patient Pack2 models · 224 reports · 2 recalls
• HeartWare Controller AC Adapter5 models · 97 reports · 3 recalls
• HVAD Pump Outflow Graft3 models · 60 reports · 2 recalls
• HVAD Pump Implant Accessories2 models · 2 reports · 3 recalls
• HeartWare Controller DC Adapter6 models · 59 reports · 1 recall