Heartware, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2072-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 28, 2021

Date Posted: July 21, 2021

Recall Number: Z-2072-2021

Event ID: 88135

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI: 00888707007139. Serial Number HW42843

Distribution Pattern:

International distribution to the country of Germany.

Voluntary or Mandated:

Voluntary: Firm initiated