Z-0005-2017Class I

HeartWare Ventricular Assist System Controller

Name: Z-0005-2017 HeartWare Ventricular Assist System Controller
Creator: Heartware, Inc.
Published: 2016-06-08
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2016-06-08 / Terminated / root cause: design

FDA source

Heartware, Inc. began a recall of HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from... on 2016-06-08. FDA classified it as Class I and gives the reason as "Loose connector ports in controller body". 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-0005-2017
Classification: Class I
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-10-17
Terminated: 2020-03-31
Recalling firm: HeartWare, Inc.
Product: 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 or helicopter
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Loose connector ports in controller body.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed "Acknowledgement Form" within 30 days and to forward the message to necessary individuals within their organization. Customers with questions were instructed to contact their local HeartWare representative. For questions regarding this recall call 305-364-1575.
Quantity in commerce: 4235 Worldwide, 7272 units in U.S.
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.
Product codes and lots: All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US. International Model No: 1400, 1401XX, 1407XX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)