Heartware, Inc. recalls Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
- Recall date
- April 3, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2058-2020
- FDA classification
- Class I
- Brand / firm
- Heartware, Inc.
- Sold / distributed
- Worldwide Distribution
Why it was recalled
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.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
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