Heartware, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0067-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Product Classification:

Class II

Date Initiated: August 28, 2018

Date Posted: October 10, 2018

Recall Number: Z-0067-2019

Event ID: 80966

Reason for Recall:

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

Status: Terminated

Product Quantity: 17,275 units

Code Information:

Serial number range: CON300175 - CON320540

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated