Heartware, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2058-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 3, 2020

Date Posted: June 3, 2020

Recall Number: Z-2058-2020

Event ID: 85397

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 20147 devices

Code Information:

All lots and serial numbers in distribution

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated