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Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Recalled June 3, 2020 · FDA recall Z-2055-2020 · 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
2614 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 1103
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →