Heartware, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1887-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

Product Classification:

Class I

Date Initiated: January 7, 2016

Date Posted: July 20, 2016

Recall Number: Z-1887-2016

Event ID: 73636

Reason for Recall:

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

Status: Terminated

Product Quantity: 18, 631

Code Information:

Serial numbers ranging BAT000001 to BAT199999.

Distribution Pattern:

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

Voluntary or Mandated:

Voluntary: Firm initiated