Skip to content
Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:187964

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.

Official recall number

Z-2072-2021

Evidence summary

Product code
DSQ
Recall status
Open, Classified
Event initiated
May 28, 2021
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2072-2021