Recall Z-0067-2019 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
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
| Date | Aug 28, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations. Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods. |
| Quantity | 17,275 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.