Heartware, Inc.: FDA recalls

FDA enforcement reports name Heartware, Inc. as the recalling firm in 32 events. The events have 72 product records. The recalls started from 2012 to 2023. All the events are device recalls.

See the 32 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

32 events, newest first.

FDA enforcement events of Heartware, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
31 Oct 2023	HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100	Device	Class II	9	Ongoing
16 May 2023	HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech	Device	Class II	1	Ongoing
29 Nov 2022	HeartWare Model 1100	Device	Class II	9	Ongoing
28 Jun 2022	HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE	Device	Class I	1	Ongoing
30 Mar 2022	HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104	Device	Class II	6	Ongoing
27 Jan 2022	HeartWare Ventricular Assist Device (HVAD) System	Device	Class II	1	Ongoing
6 Aug 2021	Medtronic HVAD Pump Implant Kits	Device	Class II	1	Ongoing
3 Jun 2021	HeartWare HVAD Pump Implant Kit, REF 1103	Device	Class I	10	Ongoing
28 May 2021	HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent…	Device	Class II	1	Terminated
26 Feb 2021	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP,…	Device	Class I	1	Ongoing
26 Feb 2021	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR,…	Device	Class II	1	Ongoing
26 Feb 2021	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR,…	Device	Class II	1	Ongoing
26 Feb 2021	Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR	Device	Class I	6	Ongoing
19 Nov 2020	Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU	Device	Class I	1	Ongoing
3 Apr 2020	Heartware HVAD Pump Implant Kit, Product (REF) Number 1103	Device	Class I	5	Ongoing
23 Jan 2020	HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent…	Device	Class I	2	Ongoing
19 Nov 2018	Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as…	Device	Class II	1	Terminated
28 Aug 2018	Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery,…	Device	Class II	1	Terminated
17 Aug 2016	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and…	Device	Class I	1	Ongoing
8 Jun 2016	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft…	Device	Class I	1	Terminated
7 Jan 2016	HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular…	Device	Class I	1	Terminated
29 Apr 2015	HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.	Device	Class I	1	Ongoing
29 Apr 2015	HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.	Device	Class II	1	Ongoing
29 Apr 2015	HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).	Device	Class I	1	Ongoing
29 Apr 2015	HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.	Device	Class I	1	Ongoing
29 Apr 2015	HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.	Device	Class II	1	Ongoing
29 Apr 2015	HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.	Device	Class I	1	Ongoing
16 Jan 2015	HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including…	Device	Class I	1	Terminated
16 Apr 2014	HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including…	Device	Class II	1	Terminated
6 Dec 2013	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and…	Device	Class I	1	Terminated
16 May 2013	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)	Device	Class II	1	Terminated
27 Dec 2012	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Heartware, Inc.: events for each product type
Type		Events
Device		32

Heartware, Inc.: events in each class
Class		Events
Class I		16
Class II		16

Share of the events of the firm in Class I: 50%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 22

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Heartware, Inc., by the year that the recall started. The largest year is 2015, with 7 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Heartware, Inc.: FDA recalls. https://recallregister.com/firm/heartware-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: FL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Heartware, Inc. have?: Class I: 16 events. Class II: 16 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Heartware, Inc.?: FDA event 93405, which the firm started on 31 Oct 2023. The first product in the record is: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
How many FDA recalls of Heartware, Inc. have the status Ongoing?: 22 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.