Home / Recalls / Medical Devices
Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Recalled June 3, 2020 · FDA recall Z-2057-2020 · 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
85 units
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 Implant Kit, Product (REF) Number 1104JP
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →