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Recall Observatory FDA recall evidence

Device product

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.

Z-0067-2019

August 28, 2018

Class II

Product summary

Firm
Heartware, Inc.
Event
Event 80966
Status
Terminated
Classification
Class II
Quantity
17,275 units
Official record key
device-enforcement:Z-0067-2019

Official wording

Reason: 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.

Code information: Serial number range: CON300175 - CON320540

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.