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Heartware Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000019976 FEI 3007042319

Heartware Inc. is a medical device manufacturer based in the United States, with 89 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class III and II; EU Class III) and 75 FDA recalls as of 13 Nov 2026.

Devices
89
Registrations
EUDAMEDFDA
FDA recalls
7547 ongoing since 2021 (65 open in total)
18 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 80
  • EUDAMED 20
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class III 73
  • EU Class III 15
  • FDA Class II 1
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000019976
  • FDA FEI 3007042319
  • DUNS 146054536

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Heartware Inc. makes

Heartware Inc. manufactures implantable ventricular circulatory assist systems, including temporary artificial heart devices, along with associated surgical tools, controllers, batteries, and accessories like shower bags and explant kits. The portfolio also includes peripheral components such as USB flash drives, alarm adapters, and AC power adapters for system compatibility.

The company’s devices are regulated under FDA classifications, with some falling under Class II and others under Class III. Products are listed in the FDA’s 510(k) and UDI registries, reflecting their authorised status for medical use in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue89

Newest first, rows 1-50 of 89

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Rows 1-50 of 89

Showing 1-50 of 89

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000019976
FDA FEI number
3007042319
DUNS number
146054536
EUDAMED status
Active
EUDAMED registered name
HeartWare, Inc.
Registered address
8200, Coral Sea St NE, MN 55112, Mounds View, United States
Phone
+1(800)633-8766
PRRC contact
William McNaughton(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 28 Aug 2029

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 737528 Active Supplemented

    Technical documentation EU MDR

    Issued
    10 Aug 2026
    Expires
    28 Aug 2029
    Reason
    Change approved

FDA recalls75

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 2
  • 2018 3
  • 2019 0
  • 2020 8
  • 2021 21
  • 2022 17
  • 2023 10
  • 2024 0
  • 2025 0
  • 2026 0

14 initiated before 2017

Showing the 10 most recent of 75 recalls.

  • 2023

    • 31 Oct 2023 Z-0475-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide Submission number: P100047
    • 31 Oct 2023 Z-0476-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0477-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0478-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0479-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0480-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0481-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0482-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 31 Oct 2023 Z-0483-2024 Class II Ongoing 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 troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components Distribution: Worldwide
    • 16 May 2023 Z-1993-2023 Class II Ongoing 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. Distribution: Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK. Submission number: P100047
Show the 25 most recent of 75 recalls

  • 2022

    • 29 Nov 2022 Z-0742-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0743-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0744-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0745-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0746-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0747-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0748-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0749-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 29 Nov 2022 Z-0750-2023 Class II Ongoing 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 may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. Distribution: Worldwide distribution.
    • 28 Jun 2022 Z-1512-2022 Class I Ongoing 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. Distribution: Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United…
      Full distribution text Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.
      Submission number: P100047
    • 30 Mar 2022 Z-1102-2022 Class II Ongoing 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. Distribution: Finland and Turkey Submission number: P100047
    • 30 Mar 2022 Z-1103-2022 Class II Ongoing 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. Distribution: Finland and Turkey Submission number: P100047
    • 30 Mar 2022 Z-1104-2022 Class II Ongoing 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. Distribution: Finland and Turkey Submission number: P100047
    • 30 Mar 2022 Z-1105-2022 Class II Ongoing 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. Distribution: Finland and Turkey Submission number: P100047
    • 30 Mar 2022 Z-1106-2022 Class II Ongoing 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. Distribution: Finland and Turkey Submission number: P100047

Frequently asked questions

How many devices does Heartware Inc. have in the registry?

The registry currently lists 89 devices for Heartware Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Heartware Inc.'s devices?

Among its 50 most recently registered devices, Heartware Inc. has devices listed in EUDAMED (19 devices) and FDA GUDID (42 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Heartware Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Heartware Inc.'s devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Heartware Inc.?

FDA recall records list 75 recalls initiated by Heartware Inc., the most recent initiated on 31 Oct 2023. 65 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Heartware Inc.?

EUDAMED lists 1 certificate for Heartware Inc. (technical documentation) under MDR. The most recent was issued on 10 Aug 2026.

What are the newest devices from Heartware Inc. in the registry?

The most recently registered devices listed for Heartware Inc. include HeartWare HVAD System, HeartWare™ Battery 1650, HeartWare™ Waist Pack 2050 and HeartWare™ Shoulder Pack 2060.

Generated automatically from registry data and not verified by a human reviewer.