HeartWare Inc: Medical Device Recall in 2015 - (Recall #: Z-1731-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Product Classification:

Class I

Date Initiated: April 29, 2015

Date Posted: June 24, 2015

Recall Number: Z-1731-2015

Event ID: 71239

Reason for Recall:

Complaints with the HVAD Internal Controller Alarm Battery failures.

Status: Ongoing

Product Quantity: 3,747 curently implanted

Code Information:

Serial #: ALL HeartWare HVAD systems currently in use.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated