Z-1323-2013Class II

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Name: Z-1323-2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Creator: Heartware Inc
Published: 2012-12-27
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2012-12-27 / Terminated / root cause: design

FDA source

Heartware Inc began a recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) on 2012-12-27. FDA classified it as Class II and gives the reason as "HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector". 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-1323-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-27
Posted: 2013-05-14
Terminated: 2013-07-09
Recalling firm: HeartWare, Inc.
Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.
Quantity in commerce: 3,544
Distribution: Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
Product codes and lots: Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1323-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)