Z-1131-2015Class I

HeartWare Ventricular Assist System (HeartWare Controller)

Name: Z-1131-2015 HeartWare Ventricular Assist System (HeartWare Controller)
Creator: HeartWare Inc
Published: 2015-01-16
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2015-01-16 / Terminated / root cause: design

FDA source

HeartWare Inc began a recall of HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death... on 2015-01-16. FDA classified it as Class I and gives the reason as "The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1131-2015
Classification: Class I
Status: Terminated
Initiated: 2015-01-16
Posted: 2015-02-25
Terminated: 2020-02-05
Recalling firm: HeartWare, Inc.
Product: HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: 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 System 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 affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare sent an URGENT MEDICAL DEVICE RECALL dated January 16, 2015 asking clinicians to quarantine the affected controllers and complete and return the acknowledgement form. HeartWare also asks clinicians to identify patients with affected controllers and review the applicable risks with the patient and as soon as reasonably possible if medically advisable, exchange the affected controller under medical supervision with a new controller. HeartWare also asks that for each patient using an affected controller as their backup to contact the patient and arrange to have the backup controller replaced with a new controller. Lastly, HeartWare asks the firm to complete the patient tracking form and return all quarantined controllers to HeartWare along with the completion form. Should you have any questions or concerns, please contact your local HeartWare representative. Our 24-Hour Clinical Support personnel are also available at 1-888-494-6365.
Quantity in commerce: 4,845
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
Product codes and lots: Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-25

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)