Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Heartware HVAD Pump Outflow Graft Recalled by Heartware, Inc. Due to The Outflow Graft may be subject to tears...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heartware, Inc. directly.
Affected Products
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Quantity: 20147 devices
Why Was This 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.
Where Was This Sold?
Worldwide Distribution
About Heartware, Inc.
Heartware, Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report