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Recall Observatory FDA recall evidence

Device product

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Z-2058-2020

April 03, 2020

Class I

Product summary

Firm
Heartware, Inc.
Event
Event 85397
Status
Ongoing
Classification
Class I
Quantity
20147 devices
Official record key
device-enforcement:Z-2058-2020

Official wording

Reason: 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.

Code information: All lots and serial numbers in distribution

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.