Heartware, Inc. recalls HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with adv…

Recall date

May 28, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2072-2021

FDA classification

Class II

Brand / firm

Heartware, Inc.

Sold / distributed

International distribution to the country of Germany.

Why it was recalled

The pump has an impeller with a shroud height that did not meet the lower control limit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.