Z-2058-2020Class I

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

Name: Z-2058-2020 Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Creator: Heartware, Inc.
Published: 2020-04-03
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2020-04-03 / Open, Classified / root cause: design

FDA source

Heartware, Inc. began a recall of Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 on 2020-04-03. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2058-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-04-03
Posted: 2020-05-22
Recalling firm: HeartWare, Inc.
Product: Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, 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. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A.
Quantity in commerce: 20147 devices
Distribution: Worldwide Distribution
Product codes and lots: All lots and serial numbers in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2056-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2057-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2058-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2059-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)