FDA-Device2018-10-10Class II
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.
Heartware, Inc.
Hazard
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.
Sold states
Worldwide Distribution
Affected count
17,275 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0067-2019Don't want to check this manually?
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