Z-1538-2017Class I

HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a...

Name: Z-1538-2017 HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a...
Creator: Heartware
Published: 2017-02-03
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2017-02-03 / Open, Classified / root cause: software

FDA source

Heartware began a recall of HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are... on 2017-02-03. FDA classified it as Class I and gives the reason as "Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1538-2017
Classification: Class I
Status: Open, Classified
Initiated: 2017-02-03
Posted: 2017-04-27
Recalling firm: HeartWare, Inc.
Product: HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) 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: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
Root cause tag: software
FDA root cause: Software design
Action: The firm will release a communication to their consignees stating the following: As a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities: " Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure. " Staff only: The driveline extension cable is to be used during the pre-implant test only. It is not intended to be used after the pump is implanted in the patient. Hospital and Clinician Actions (to be executed in the following order): 1) Review the enclosed notice and forms, and forward the notice to those individuals within your organization who need to be aware of its contents. 2) Complete, sign, and return the Acknowledgement Form to HeartWare within thirty (30) days of receipt of this letter. 4) Quarantine and replace affected HVAD Controllers, DC Adapters, Instructions for Use, Emergency Responder Guides and Patient Manuals in hospital inventory after training is complete. For every patient, quarantine and replace the following under clinical supervision in an environment where appropriate support equipment is readily available: - Primary and Backup HVAD Controller; - Affected DC Adapters; and - Patient Manual and Emergency Responder Guide. Clinicians are reminded not to perform an HVAD Controller exchange during an active electrical fault alarm as the HVAD Pump will be running a single stator. If an electrical fault is present, download patient log files and contact your HeartWare representative to resolve the electrical fault before executing the controller exchange. 5) Return all quarantined HVAD Controllers and DC Adapters to HeartWare. Your HeartWare representative will assist you with this process. 6) Completion Form. Once affected product in inventory has been identified and returned, complete and return the attached Completion Form to [email protected] or your HeartWare representative no late
Quantity in commerce: 8,343 US and 13,145 INTERNATIONAL
Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, 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 Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.
Product codes and lots: HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1538-2017	Class I	Ongoing	Voluntary: Firm initiated	2017-05-03	2017-04-26

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)