Home / Recalls / Medical Devices
Heartware, Inc. recalls HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with adva
Recalled July 21, 2021 · FDA recall Z-2072-2021 · Heartware
Hazard
The pump has an impeller with a shroud height that did not meet the lower control limit. · FDA Class II
Units
1 unit
Sold at
International distribution to the country of Germany.
Description
The pump has an impeller with a shroud height that did not meet the lower control limit.
Product
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.
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →