Recall Z-0067-2019— Heartware, Inc.
Class II · Terminated
Class II FDA medical device recall by Heartware, Inc., initiated 2018-08-28, terminated 2019-04-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-28
- Terminated
- 2019-04-05
- Firm location
- Miami Lakes, FL, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.