Z-1726-2015Class I

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205...

Name: Z-1726-2015 HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205...
Creator: HeartWare Inc
Published: 2015-04-29
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2015-04-29 / Open, Classified / root cause: design

FDA source

HeartWare Inc began a recall of HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac... on 2015-04-29. FDA classified it as Class I and gives the reason as "Complaints with the HVAD Retraction of Pins within the driveline connector". 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-1726-2015
Classification: Class I
Status: Open, Classified
Initiated: 2015-04-29
Posted: 2015-06-11
Recalling firm: HeartWare, Inc.
Product: HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Complaints with the HVAD Retraction of Pins within the driveline connector.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction letters, dated APR2015, were sent to users. The letters identified the affected device, as well as the reason for the recall and risks involved. Users were asked to review and familiarize themselves with the notice and "Patient Communication." The notice should be forwarded to anyone within customers' organization that need to be aware. Customers are to identify their patients who are currently supported by the HVAD System and distribute the "Patient Communication" to them. A HeartWare representative can assist with that process is needed. Customers should continue to reinforce the messages in the notice with their patients. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of receipt of the notice. Questions or concerns should be directed to a local HeartWare representative. Clinical Support is also available at 1-888-494-6365.
Quantity in commerce: 3,747 currently in use
Distribution: Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
Product codes and lots: Serial #: ALL HeartWare HVAD systems currently in use.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1726-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1726-2015	Class I	Ongoing	Voluntary: Firm initiated	2015-06-17	2015-06-11

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)