HeartWare Inc: Medical Device Recall in 2015 - (Recall #: Z-1698-2015)

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. Product Usage: For use as a bridge-to-cardiac transplantation in patient 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 17, 2015

Recall Number: Z-1698-2015

Event ID: 71164

Reason for Recall:

HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

Status: Ongoing

Product Quantity: 3,747 currently implanted worldwide

Code Information:

Serial #: ALL HeartWare HVAD systems currently in use.

Distribution Pattern:

Worldwide Distribution - US Nationwide in 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, VA and 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