HeartWare® Battery 1650 (UDI 00888707000376)Recalls & reported problems

Summary

The FDA's MAUDE database contains 740 adverse event reports that list this exact device (DI 00888707000376), received between Jun 16, 2016 and Aug 16, 2022 — classified as 4 injuries, 736 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (643 reports).

3 FDA recall records name this device's identifier, 3 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, 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. 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 · FDA record ↗

2. 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 · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 740 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS POWER SWITCHING. 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 15236809 ↗
• MalfunctionJun 24, 2022Battery Problem; Battery Problem

  IT WAS REPORTED BY THE MANUFACTURER THAT WHILE REVIEWING LOG FILE DATA FOR A PRIOR EVENT, THE DATA REVEALED A 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 14806971 ↗
• MalfunctionMar 3, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING. THE BATTERIES 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 13663969 ↗
• MalfunctionNov 18, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT BATTERIES WERE NOT CHARGING. 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 12836270 ↗
• MalfunctionAug 10, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY INDICATOR LIGHT WAS NOT FUNCTIONING ON THE BATTERIES. THE BATTERIES 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 12302918 ↗
• MalfunctionMay 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BATTERY HAD A DAMAGED CABLE. THE OUTER COVERING OF THE CABLE WAS WORN AND TORN, EXPOSING THE WIRES. THE BATTERY WAS REMOVED 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 11841940 ↗
• MalfunctionApr 23, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A POWER DISCONNECT. 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 11716825 ↗
• MalfunctionMar 22, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN APPROPRIATE CRITICAL BATTERY ALARM WHEN TWO POWER SOURCES WERE CONNECTED. THE BATTERY CAPACITY AT THE TIME OF THE ALARM WAS 8%. 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 11541938 ↗
• MalfunctionJan 19, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED A COMMUNICATION ERROR SEVERAL TIMES. 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 11193423 ↗
• MalfunctionDec 22, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXHIBITED POWER SWITCHING. THE ISSUE OCCURRED WHEN CONNECTED TO EITHER SIDE OF THE CONTROLLER. AFTER ABOUT FIVE MINUTES, THE CONTROLLER WAS SWITCHING OVER TO THE OTHER BATTERY EVEN WHEN THE CONTROLLER STATED THE BATTERY WAS THREE-QUARTERS TO ONE HUNDRED PERCENT FULL. 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 11059512 ↗
• MalfunctionOct 5, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED SUSPECTED POWER SWITCHING ASSOCIATED WITH POTENTIAL OXIDATION. IT WAS ALSO REPORTED THAT ONE OF THE BATTERIES EXHIBITED A COMMUNICATION ERROR ASSOCIATED WITH MULTIPLE POWER DISCONNECT ALARMS, AND THE OTHER BATTERY WAS ASSOCIATED WITH AN ERRONEOUS CRITICAL BATTERY ALARM. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10626986 ↗
• MalfunctionAug 6, 2020Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT MULTIPLE BATTERIES EXHIBITED POOR MECHANICAL CONNECTIONS. ONE BATTERY FELL OUT OF THE POWER PORT WHEN CONNECTED TO THE CONTROLLER AND TWO OTHER BATTERIES DID NOT "SPRING BACK". THE CONNECTORS WERE WORN, AND IT WAS SUSPECTED THAT THEY WERE CONTAMINATED WHICH PREVENTED THEM FROM SECURELY CONNECTING. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10373294 ↗
• MalfunctionJun 17, 2020Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA DUE TO THE BATTERY UNUSUAL/ABNORMAL CYCLE COUNT. 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 Consequences Or Impact To Patient

  MAUDE report 10163388 ↗
• MalfunctionJun 9, 2020Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THE BATTERIES WERE EXCHANGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132773 ↗
• MalfunctionApr 1, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY WAS NOT LASTING AS LONG. THE BATTERY WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910985 ↗
• MalfunctionJan 27, 2020Battery Problem; Battery Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9631795 ↗
• MalfunctionJan 21, 2020Battery Problem; Battery Problem

  THE BATTERY WAS RETURNED TO THE MANUFACTURER BECAUSE IT WAS NOT CHARGING. THE BATTERY SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THE PATIENT IS A PARTICIPANT IN THE ENDURANCE SUPPLEMENTAL TRIAL IMPROVED BLOOD PRESSURE MANAGEMENT CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611252 ↗
• MalfunctionDec 16, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED ERRONEOUS CRITICAL BATTERY ALARM AND POWER DISCONNECT ALARMS. THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9476628 ↗
• MalfunctionDec 16, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THERE WAS POWER SWITCHING AND THE CONTROLLER ALARMED WITH NO MESSAGE. FOUR BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9476395 ↗
• MalfunctionDec 3, 2019Battery Problem; Battery Problem

  THE BATTERIES WERE REMOVED FROM SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9400899 ↗
• MalfunctionNov 13, 2019Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA DUE TO ABNORMAL CYCLE COUNTS. THE BATTERIES SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316078 ↗
• MalfunctionSep 20, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT AFTER ROUTINE LOG FILE REVIEW A BATTERY WAS INDICATED TO HAVE HAD A COMMUNICATION ERROR. THE BATTERY REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100764 ↗
• MalfunctionSep 17, 2019Battery Problem; Connection Problem; Battery Problem; Connection Problem

  IT WAS REPORTED THAT THE BATTERY HAD A POOR MECHANICAL CONNECTION AND POWER DISCONNECT ALARMS. AFTER ROUTINE LOG FILE REVIEW, IT WAS INDICATED THAT THE BATTERY HAD A COMMUNICATION ERROR. THE BATTERY WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9077742 ↗
• MalfunctionSep 16, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES EXHIBITED POWER SWITCHING. LUBRICATION SERVICING WAS PERFORMED AND THE BATTERIES REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9071048 ↗
• MalfunctionSep 11, 2019Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE DRAINING QUICKER THAN NORMAL, DROPPING BARS, AND SWITCHING TO THE OTHER SIDE. THE PATIENT STATED THAT FULLY CHARGED BATTERIES WERE BEING PLUGGED IN TO THE CONTROLLER AND WITHIN ONE TO TWO HOURS THEY WERE DROPPING DOWN TO ONE BAR. THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8993050 ↗