HeartWare® Controller 1403US (UDI 00888707000116)Recalls & reported problems

Summary

The FDA's MAUDE database contains 898 adverse event reports that list this exact device (DI 00888707000116), received between Jan 21, 2016 and May 5, 2022 — classified as 5 deaths, 5 injuries, 887 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (353 reports).

1 FDA recall record name this device's identifier, 1 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. 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 898 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Electrical /Electronic Property Problem; Data Problem; Electrical /Electronic Property Problem; Data Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED INTERMITTENT ALARMS OVER A TWENTY-FOUR HOUR PERIOD. IT WAS ALSO REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM AND THERE WAS AN INCOMPLETE DATA TRANSFER FROM THE CONTROLLER TO THE MONITOR. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288101 ↗
• MalfunctionApr 1, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604033 ↗
• MalfunctionFeb 8, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED AN UNEXPECTED LOSS OF POWER. THE CONTROLLER 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 11294158 ↗
• MalfunctionJan 4, 2021Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DUE TO A DEPLETED INTERNAL BATTERY. THE CONTROLLER ALSO EXHIBITED AN UNEXPECTED POWER LOSS. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109519 ↗
• MalfunctionNov 17, 2020Power Problem; Power Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN ALARM THAT SUBSIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10851804 ↗
• MalfunctionOct 19, 2020Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONTROLLER EXHIBITED A POOR MECHANICAL CONNECTION DUE TO A BROKEN POWER PORT. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701924 ↗
• MalfunctionOct 16, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THERE WAS AN UNEXPECTED LOSS OF POWER TO THE CONTROLLER. THE CONTROLLER REMAINS IN USE. 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 10692336 ↗
• MalfunctionFeb 19, 2020Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE CONTROLLER HAD A DATE/TIME ERROR. IT WAS NOTED THAT THE PATIENT WAS LOST TO FOLLOW UP AND THIS WAS AN OLDER MODEL CONTROLLER. THE CONTROLLER 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 9729630 ↗
• MalfunctionNov 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CONTROLLER HAD A BENT PIN ON POWER PORT ONE. THE CONTROLLER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9336891 ↗
• DeathOct 16, 2019Disconnection; Power Problem; Disconnection; Power Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT WAS FOUND DOWN AT HOME WITH NO BATTERIES CONNECTED TO THE CONTROLLER. THE CONTROLLER HAD LOGGED THREE UNEXPECTED LOSSES OF POWER. IT WAS ALSO NOTED THAT THE PATIENT¿S WIFE INDICATED THE PATIENT REPORTED NOT FEELING QUITE RIGHT THAT DAY.

  Patient problems: Death

  MAUDE report 9198096 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942912 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942911 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942909 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942906 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942905 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8942780 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8939588 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8939571 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8939557 ↗
• MalfunctionAug 28, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8939418 ↗
• MalfunctionAug 27, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8937220 ↗
• MalfunctionAug 27, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8937111 ↗
• MalfunctionAug 27, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8937093 ↗
• MalfunctionAug 27, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8937050 ↗
• MalfunctionAug 27, 2019Power Problem; Power Problem

  IT WAS REPORTED AFTER LOG FILE REVIEW THAT THE CONTROLLER EXPERIENCED LOSS OF POWER EVENT(S). THE CONTROLLER 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 8936822 ↗