medical Class I Updated 2020-06-03

Heartware, Inc. recalls Heartware HVAD Pump Implant accessories, Product (REF) Numbe

Recalled Product

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: GTIN 00888707000147, All lot numbers in distribution
View official government recall

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