Z-0006-2017Class I

HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model...

Name: Z-0006-2017 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model...
Creator: HeartWare, Inc
Published: 2016-08-17
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2016-08-17 / Open, Classified / root cause: design

FDA source

HeartWare, Inc began a recall of HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a... on 2016-08-17. FDA classified it as Class I and gives the reason as "Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0006-2017
Classification: Class I
Status: Open, Classified
Initiated: 2016-08-17
Posted: 2016-10-13
Recalling firm: HeartWare, Inc.
Product: HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. 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: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Root cause tag: design
FDA root cause: Component design/selection
Action: HeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104. The letter discussed the reason for the recall as well as the risk to health. Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form. Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665. Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned. Questions or concerns should be directed to a local HeartWare representative.
Quantity in commerce: 344 pumps
Distribution: Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
Product codes and lots: All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0006-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0006-2017	Class I	Ongoing	Voluntary: Firm initiated	2016-10-19	2016-10-13

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)