HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: 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.
The pump has an impeller with a shroud height that did not meet the lower control limit.
International distribution to the country of Germany.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2021