Z-1471-2014Class I

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102...

Name: Z-1471-2014 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102...
Creator: HeartWare Inc
Published: 2013-12-06
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2013-12-06 / Terminated / root cause: manufacturing process

FDA source

HeartWare Inc began a recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac... on 2013-12-06. FDA classified it as Class I and gives the reason as "The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1471-2014
Classification: Class I
Status: Terminated
Initiated: 2013-12-06
Posted: 2014-04-23
Terminated: 2016-11-03
Recalling firm: HeartWare, Inc.
Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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 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: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their hospitals and doctors on December 12, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. For already implanted patients, arrange a follow up visit at the earliest convenience to check patient's driveline connector. They were asked to sign and return the Acknowledgement Form to HeartWare. For questions, contact your HeartWare Representative or HeartWare Customer Service at 1-877-367-4823.
Quantity in commerce: 4,586
Distribution: Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.
Product codes and lots: Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1471-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1471-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-22

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)