Z-1607-2014Class II

HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a...

Name: Z-1607-2014 HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a...
Creator: HeartWare Inc
Published: 2014-04-16
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2014-04-16 / Terminated

FDA source

HeartWare Inc began a recall of HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at... on 2014-04-16. FDA classified it as Class II and gives the reason as "Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1607-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-05-14
Terminated: 2016-10-03
Recalling firm: HeartWare, Inc.
Product: HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare 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: Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
FDA root cause: Under Investigation by firm
Action: HeartWare sent an Urgent Medical Device Correction letter dated April 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to familiarize themselves with the letter and review their Patient Manual about proper power management. Discuss with their VAD Coordinator any questions they may have about the HeartWare System or the letter. Always keep two (2) power sources connected to your controller; never leave your controller connected to only one (1) power source except while briefly switching to another power source. " Review the recommended practices for power management provided later in this letter. If a battery shows any of the abnormal battery behaviors described, stop using that battery and contact your VAD Coordinator immediately to replace it. Customers were instructed to confirm that they have received and understood the information. Sign and return the enclosed Confirmation form as soon as they can to HeartWare in the prepaid self-addressed envelope or by fax to 1-305-364-2665. For questions customers were instructed to contact their doctor or VAD coordinator. For questions regarding this recall call 305-364-1575.
Quantity in commerce: 32,349
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.
Product codes and lots: Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1607-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1607-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-14

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)