Heartware, Inc. recalls Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Recalled June 3, 2020 · FDA recall Z-2058-2020 · Heartware

Hazard

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. · FDA Class I

Units

20147 devices

Sold at

Worldwide Distribution

Description

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Product

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Manufacturer(s)

Heartware, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →