CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report

Ventricular Assist Device (HVAD) System Controller recalled by Heartware

Heartware is recalling HeartWare Ventricular Assist Device (HVAD) System Controller. The recall was initiated on 30 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872

Quantity recalled59 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1105-2022
FDA event ID: 90079
Recalling firm: Heartware, Miami Lakes, FL
Classification: Class II
Status: Ongoing
Recall initiated: 30 Mar 2022
FDA classified: 17 May 2022
Reported: 25 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Mar 2022	Recall initiated by company
17 May 2022	Classified by FDA	+48 days
25 May 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

Where it was distributed

Finland and Turkey

Questions about this recall

Is Ventricular Assist Device (HVAD) System Controller recalled?

Yes. Heartware recalled Ventricular Assist Device (HVAD) System Controller on 30 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1105-2022.

Why was it recalled?

Which lots are affected?

GTIN 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872

Where was it sold?

Finland and Turkey

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Heartware

All 69

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	1104CA-Clin - Hvad (HeartWare Ventricular Assist Device) Pump recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Sterile Hvad (HeartWare Ventricular Assist Device) Pump (US) recalled	Heartware	Sterility	FL
13 Dec 2023Device	CLASS II	Pump MCS1705PU Hvad (HeartWare Ventricular Assist Device) recalled	Heartware	Device Malfunction	FL
13 Dec 2023Device	CLASS II	Hvad (HeartWare Ventricular Assist Device) Sterile Implant Kit recalled	Heartware	Sterility	FL

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