Recall Atlas

Heartware recalls

6 official recalls and safety alerts involving Heartware since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Heartware or the relevant agency.

  1. 2023-12-13
  2. US
    Drugs & medicalClass II

    Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

    Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended…

    FDA · DeviceHeartware, Inc.WorldwideOfficial notice →
  3. 2023-06-28
  4. US
    Drugs & medicalClass II

    Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore…

    Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.

    FDA · DeviceHeartware, Inc.Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the…Official notice →
  5. 2022-12-28
  6. US
    Drugs & medicalClass II

    Heartware, Inc. recalls HeartWare Model 1100

    Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which…

    FDA · DeviceHeartware, Inc.Worldwide distribution.Official notice →
  7. 2022-08-24
  8. US
    Drugs & medicalClass I

    Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

    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…

    FDA · DeviceHeartware, Inc.Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile,…Official notice →
  9. 2022-05-25
  10. US
    Drugs & medicalClass II

    Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

    Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

    FDA · DeviceHeartware, Inc.Finland and TurkeyOfficial notice →
  11. 2022-03-16
  12. US
    Drugs & medicalClass II

    Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System

    Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is…

    FDA · DeviceHeartware, Inc.Distribution throughout the United States. OUS distribution in Argentina,…Official notice →