HeartWare® Battery 1650DE (UDI 00888707008778)Recalls & reported problems

Summary

The FDA's MAUDE database contains 606 adverse event reports that list this exact device (DI 00888707008778), received between Jan 15, 2021 and Nov 5, 2024 — classified as 2 injuries, 604 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (580 reports).

2 FDA recall records name this device's identifier, 2 still open.

58 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.

Recalls naming this device

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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 606 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BATTERY HAD TEARING ALONG THE CABLE INSULATION WITH WIRES EXPOSED. THE BATTERY REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS EVENT WAS REPORTED IN THE Q2 2024 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610589 ↗
• MalfunctionOct 22, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED THAT THE BATTERY EXHIBITED A CRITICAL BATTERY ALARM DUE TO COMMUNICATION ERROR. THE BATTERY REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506661 ↗
• MalfunctionFeb 27, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING LOG FILE REVIEW THE BATTERY EXHIBITED COMMUNICATION ERRORS. THE BATTERY REMAINS IN USE. NO PATIENT COMPL ICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790149 ↗
• MalfunctionDec 5, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A DISPLAY ERROR. WHEN A FULLY CHARGED BATTERY WAS CONNECTED TO THE CONTROLLER, THE BATTERY CHARGE CAPACITY INDICATOR WILL NOT DISPLAY THE BATTERY LED BARS. 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 18271934 ↗
• MalfunctionOct 18, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT, WHEN THE BATTERY WAS PLACED ON THE BATTERY CHARGER, THE INDICATOR LIGHT WAS FLASHING RED. THE BATTERY WAS EXCH ANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958221 ↗
• MalfunctionSep 27, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 17825728 ↗
• MalfunctionSep 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A BATTERY WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT C COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825689 ↗
• MalfunctionSep 27, 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 17825120 ↗
• MalfunctionAug 25, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A COMMUNICATION ERROR.  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 17624329 ↗
• MalfunctionAug 21, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT BOTH BATTERIES WERE "TOTALLY CHARGED AFTER 6 HOURS OF USAGE". 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 17585470 ↗
• MalfunctionAug 1, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS FULLY CHARGED AND WHEN USED IT WOULD DISCHARGE TO TWO BARS AND SWITCH TO THE OTHER BATTERY. 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 17434948 ↗
• MalfunctionJul 26, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THAT THE BATTERY WAS NOT CHARGING. 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 17398542 ↗
• MalfunctionJul 25, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DID NOT PROVIDE POWER AND EXHIBITED A DISCONNECT ALARM EVEN WHEN BATTERY WAS CONNECTED. 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 17389066 ↗
• MalfunctionJul 18, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY HAD ONLY FIVE HOURS AND THIRTY FIVE MINUTES OF CAPACITY. 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 17342635 ↗
• MalfunctionJul 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BATTERY COULD NOT BE DETACHED FROM THE CONTROLLER. AFTER SEVERAL TRIES THE BATTERY WAS ABLE TO BE REMOVED. NO BENT PINS OR DAMAGE WAS SEEN ON 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 17288947 ↗
• MalfunctionJul 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 17268666 ↗
• MalfunctionJul 6, 2023Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA AND THE BATTERY SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. 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 17268641 ↗
• MalfunctionJul 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. THE BATTERY IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266800 ↗
• MalfunctionJul 3, 2023Battery Problem; Battery Problem

  IT WAS REPORTED 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 17248772 ↗
• MalfunctionJun 29, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. THE BATTERY WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225104 ↗
• MalfunctionJun 28, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. THE BATTERY WAS REMOVED FROM THE SHELF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217442 ↗
• MalfunctionJun 23, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE BATTERY WAS RETURNED TO THE MANUFACTURER BECAUSE THE BATTERY HAD A DISPLAY ERROR AND THE LIGHT-EMITTING DIODE (LED) WAS WORKING INTERMITTENTLY. THE BATTERY 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 17190989 ↗
• MalfunctionJun 23, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING AND THE INDICATOR LAMP AT THE BATTERY CHARGER WAS SHINING IN RED. 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 17190740 ↗
• MalfunctionJun 22, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING, THE BATTERY CHARGER RED LED LIGHT KEPT BLINKING. 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 17182708 ↗
• MalfunctionJun 22, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING. 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 17182676 ↗

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-1207-2022 · Apr 14, 2022 · Open, Classified
  HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• 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-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-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-1102-2022 · Mar 30, 2022 · Open, Classified
  HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
• 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-2192-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Driveline Extension Cable, REF 100
• Z-2194-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Implant Kit, REF 1104JP
• Z-2197-2021 · Jun 3, 2021 · Open, Classified
  HeartWare HVAD Pump Accessories, REF MCS1753AK

…and 43 more.