HeartWare® Battery 1650 (UDI 00888707000079)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888707000079), received between Jan 13, 2016 and Dec 21, 2017 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CONTROLLER DID NOT RECOGNIZE THE BATTERY WHEN IT WAS CONNECTED. ADDITIONALLY THE BATTERY CAUSED A YELLOW LIGHT ON THE BATTERY CHARGER. TWO 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 7139653 ↗
• MalfunctionNov 8, 2016Battery Problem; Battery Problem

  IT WAS REPORTED FROM THE US THAT DURING A CLINIC VISIT, THE PATIENT REPORTED THAT ONE OF HIS BATTERIES ONLY HOLDS CHARGE FOR 1 HOUR. NO REPORTED CONSEQUENCES OR IMPACT TO PATIENT. THE HOSPITAL REPLACED THE BATTERY AND NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087098 ↗
• MalfunctionAug 23, 2016Loss of Power; Loss of Power

  DURING TESTING AND INVESTIGATION IT WAS FOUND THAT THE BATTERY FAILED FUNCTIONAL TESTING DUE A FAULTY WELD ON CELL PACK #3.͊

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5896400 ↗
• MalfunctionApr 27, 2016Power Problem; Power Problem

  IT WAS REPORTED THAT WHILE AT HOME, A PATIENT EXPERIENCED A BATTERY NO POWER AND WILL NOT CHARGE WHEN CONNECTED TO THE BATTERY CHARGER. THE BATTERY WAS REPLACED WITH NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5612337 ↗
• InjuryMar 9, 2016Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT STATES THAT WHEN HE HOOKS THIS BATTERY UP TO A CHARGER, THE CHARGER WILL DISPLAY A FLASHING YELLOW LIGHT AND THIS OCCURS IN MULTIPLE SLOTS. THE BATTERY WAS TAKEN OUT OF SERVICE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5489106 ↗
• MalfunctionMar 4, 2016Battery Problem; Battery Problem

  IT WAS REPORTED THAT A PATIENT WAS AT HOME AND PLACED THE BATTERY ON CHARGER AND REALIZED IT WAS NOT ACCEPTING A CHARGE. (B)(4) WAS TAKEN OUT OF SERVICE TO BE RETURNED TO HEARTWARE AND REPLACED WITH BATTERY (B)(4). THERE WAS NO EFFECT OF THE DEVICE ISSUE ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5481093 ↗
• MalfunctionMar 3, 2016Battery Problem; Battery Problem

  IT WAS REPORTED THAT A (B)(4) STUDY PATIENT WAS SEEN IN CLINIC FOR ROUTINE VISIT COMPLAINING OF A BATTERY NOT CHARGING WHEN PLUGGED INTO CHARGER. THE PATIENT TRIED THE BATTERY IN SEVERAL DIFFERENT BATTERY BAYS AND WAS NOT ABLE TO OBTAIN A CHARGE. HE IS NOT HAVING THIS PROBLEM WITH ANY OTHER BATTERY AS OTHER BATTERIES ARE CHARGING IN ALL BATTERY CHARGER SLOTS. THERE ARE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5477903 ↗
• MalfunctionJan 13, 2016Connection Problem; Connection Problem

  THE SITE REPORTED THAT THIS PATIENT HAD MULTIPLE "BATTERY PROBLEMS" INCLUDING DOUBLE DISCONNECTS. PER MANUFACTURER'S REPRESENTATIVE THE SITE WAS REQUESTED TO HAVE THE COME IN TO CLINIC WITH ALL OF HIS EQUIPMENT. THE PATIENT FELT LIKE HE HAD TWO POWER SOURCES CONNECTED. IT WAS FURTHER CLARIFIED BY THE MANUFACTURER'S REPRESENTATIVE THAT THE DOUBLE DISCONNECTS REFERRED TO CONTROLLER POWER UP AND MOTOR START AND THERE WAS NOT POWER SWITCHING BETWEEN TWO POWER SOURCES WHILE CONNECTED. THE MANUFACTURER'S REPRESENTATIVE SPENT TIME WITH THE PATIENT IN THE CLINIC AND MANUFACTURING ENGINEERS. EACH BATTERY WAS REVIEW WITH A "MICROSCOPIC CAMERA". EACH PIECE OF EQUIPMENT INCLUDING WAS EXAMINED AND THE AC ADAPTER AND BATTERIES WERE REPLACED AS SEVERAL BENT PINS NOTED IN THESE DEVICES. THE CONTROLLER WAS EXAMINED AND WAS CLEANED BY THE MANUFACTURER'S REPRESENTATIVE WITH NO DAMAGE SEEN. TIME WAS SPENT GOING OVER WITH THE PATIENT HOW TO MAKE A GOOD CONNECTION AND DISCONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5363436 ↗
• MalfunctionJan 13, 2016Connection Problem; Connection Problem

  THE SITE REPORTED THAT THIS PATIENT HAD MULTIPLE "BATTERY PROBLEMS" INCLUDING DOUBLE DISCONNECTS. PER MANUFACTURER'S REPRESENTATIVE THE SITE WAS REQUESTED TO HAVE THE COME IN TO CLINIC WITH ALL OF HIS EQUIPMENT. THE PATIENT FELT LIKE HE HAD TWO POWER SOURCES CONNECTED. IT WAS FURTHER CLARIFIED BY THE MANUFACTURER'S REPRESENTATIVE THAT THE DOUBLE DISCONNECTS REFERRED TO CONTROLLER POWER UP AND MOTOR START AND THERE WAS NOT POWER SWITCHING BETWEEN TWO POWER SOURCES WHILE CONNECTED. THE MANUFACTURER'S REPRESENTATIVE SPENT TIME WITH THE PATIENT IN THE CLINIC AND MANUFACTURING ENGINEERS. EACH BATTERY WAS REVIEW WITH A "MICROSCOPIC CAMERA". EACH PIECE OF EQUIPMENT INCLUDING WAS EXAMINED AND THE AC ADAPTER AND BATTERIES WERE REPLACED AS SEVERAL BENT PINS NOTED IN THESE DEVICES. THE CONTROLLER WAS EXAMINED AND WAS CLEANED BY THE MANUFACTURER'S REPRESENTATIVE WITH NO DAMAGE SEEN. TIME WAS SPENT GOING OVER WITH THE PATIENT HOW TO MAKE A GOOD CONNECTION AND DISCONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5363425 ↗
• MalfunctionJan 13, 2016Connection Problem; Connection Problem

  THE SITE REPORTED THAT THIS PATIENT HAD MULTIPLE "BATTERY PROBLEMS" INCLUDING DOUBLE DISCONNECTS. PER MANUFACTURER'S REPRESENTATIVE THE SITE WAS REQUESTED TO HAVE THE COME IN TO CLINIC WITH ALL OF HIS EQUIPMENT. THE PATIENT FELT LIKE HE HAD TWO POWER SOURCES CONNECTED. IT WAS FURTHER CLARIFIED BY THE MANUFACTURER'S REPRESENTATIVE THAT THE DOUBLE DISCONNECTS REFERRED TO CONTROLLER POWER UP AND MOTOR START AND THERE WAS NOT POWER SWITCHING BETWEEN TWO POWER SOURCES WHILE CONNECTED. THE MANUFACTURER'S REPRESENTATIVE SPENT TIME WITH THE PATIENT IN THE CLINIC AND MANUFACTURING ENGINEERS. EACH BATTERY WAS REVIEW WITH A "MICROSCOPIC CAMERA". EACH PIECE OF EQUIPMENT INCLUDING WAS EXAMINED AND THE AC ADAPTER AND BATTERIES WERE REPLACED AS SEVERAL BENT PINS NOTED IN THESE DEVICES. THE CONTROLLER WAS EXAMINED AND WAS CLEANED BY THE MANUFACTURER'S REPRESENTATIVE WITH NO DAMAGE SEEN. TIME WAS SPENT GOING OVER WITH THE PATIENT HOW TO MAKE A GOOD CONNECTION AND DISCONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5363416 ↗