Z-2072-2021Class II

HeartWare, HVAD Pump Implant Kit, REF MCS1705PU -

Name: Z-2072-2021 HeartWare, HVAD Pump Implant Kit, REF MCS1705PU -
Creator: Heartware, Inc.
Published: 2021-05-28
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2021-05-28 / Open, Classified / root cause: manufacturing process

FDA source

Heartware, Inc. began a recall of HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart... on 2021-05-28. FDA classified it as Class II and gives the reason as "The pump has an impeller with a shroud height that did not meet the lower control limit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2072-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-28
Posted: 2021-07-13
Recalling firm: HeartWare, Inc.
Product: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: The pump has an impeller with a shroud height that did not meet the lower control limit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall to the sole consignee on 05/28/2021 by telephone. The consignee was asked to quarantine and return the affected device.
Quantity in commerce: 1 unit
Distribution: International distribution to the country of Germany.
Product codes and lots: UDI: 00888707007139. Serial Number HW42843

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2072-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2072-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13

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)