Z-0067-2019Class II

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420

Name: Z-0067-2019 Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420
Creator: Heartware, Inc.
Published: 2018-08-28
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2018-08-28 / Terminated / root cause: design

FDA source

Heartware, Inc. began a recall of Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for... on 2018-08-28. FDA classified it as Class II and gives the reason as "Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0067-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-28
Posted: 2018-10-03
Terminated: 2019-04-05
Recalling firm: HeartWare, Inc.
Product: 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, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations. Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods.
Quantity in commerce: 17,275 units
Distribution: Worldwide Distribution
Product codes and lots: Serial number range: CON300175 - CON320540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0067-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0067-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)