Z-1917-2015Class II

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are...

Name: Z-1917-2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are...
Creator: HeartWare Inc
Published: 2015-04-29
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2015-04-29 / Open, Classified / root cause: software

FDA source

HeartWare Inc began a recall of 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... on 2015-04-29. FDA classified it as Class II and gives the reason as "Complaints with the HVAD Abnormal Power Source Switching". 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-1917-2015
Classification: Class II
Status: Open, Classified
Initiated: 2015-04-29
Posted: 2015-06-26
Recalling firm: HeartWare, Inc.
Product: 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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Complaints with the HVAD Abnormal Power Source Switching.
Root cause tag: software
FDA root cause: Software design
Action: HeartWare sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the enclosed Patient Communication and familiarize the contents, forward the notice to those individuals withing their organization who need to be aware of its contents, identify their patients currently supported by the HVAD System, distribute the Patient Communication to their patients via FedEX or some other reliable means of communication. Customers with questions were instructed to contact their HeartWare representative should they need any assistance with the process. Customers were asked to complete, sign, and return the Acknowledgement and Completion Form to HeartWare. Customers with quesitons were instructed to call 1-888-494-6365.
Quantity in commerce: 3,747 currently in use.
Distribution: US including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
Product codes and lots: Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1917-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1917-2015	Class II	Ongoing	Voluntary: Firm initiated	2015-07-08	2015-06-26

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)