Z-1698-2015Class I

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP...

Name: Z-1698-2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP...
Creator: HeartWare Inc
Published: 2015-04-29
License: https://open.fda.gov/license/

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

FDA source

HeartWare Inc began a recall of HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a... on 2015-04-29. FDA classified it as Class I and gives the reason as "HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1698-2015
Classification: Class I
Status: Open, Classified
Initiated: 2015-04-29
Posted: 2015-06-08
Recalling firm: HeartWare, Inc.
Product: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: 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: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare sent an Urgent Medical Device Correction letter to customers on May 25, 2015. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Review the enclosed notice and Patient Communication. 2. Forward the notice to those individuals within their organization who need to be aware of its contents. 3. Identify the patients currently supported by the HVAD System. 4. Distribute the "Patient Communication" to their patients directly via FedEx or some other reliable means of communication. 5. Continue to reinforce the messages set forth in the notice with their patients during their regularly scheduled appointments. 6. Complete, sign and return the Acknowledgement and Completion Form to HeartWare within 30 days of receipt of this letter. For questions contact your local HeartWare representative or the 24-Hour Clinical Support personnel at 1-888-494-6365.
Quantity in commerce: 3,747 currently implanted worldwide
Distribution: Worldwide Distribution - US Nationwide in the states of 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 countries of 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, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
Product codes and lots: Serial #: ALL HeartWare HVAD systems currently in use.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1698-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2015	Class I	Ongoing	Voluntary: Firm initiated	2015-06-17	2015-06-08

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)