medical Class II Updated 2021-07-21

Heartware, Inc. recalls HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Us

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: International distribution to the country of Germany.
Lot/Code Info: UDI: 00888707007139. Serial Number HW42843
View official government recall

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