Z-1813-2013Class II

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Name: Z-1813-2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Creator: HeartWare Inc
License: https://open.fda.gov/license/

HeartWare, Inc. / Terminated / root cause: design

FDA source

HeartWare Inc began a recall of Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device). FDA classified it as Class II and gives the reason as "Potential to electrostatic discharged (ESD)". 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-1813-2013
Classification: Class II
Status: Terminated
Posted: 2013-07-29
Terminated: 2019-08-05
Recalling firm: HeartWare, Inc.
Product: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Potential to electrostatic discharged (ESD)
Root cause tag: design
FDA root cause: Device Design
Action: HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to [email protected]. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.
Quantity in commerce: 76 (US) and 82 (International)
Distribution: Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Product codes and lots: US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1813-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1813-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)