Z-0726-2022Class II

HeartWare Ventricular Assist Device (HVAD) System

Name: Z-0726-2022 HeartWare Ventricular Assist Device (HVAD) System
Creator: Heartware, Inc.
Published: 2022-01-27
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2022-01-27 / Open, Classified / root cause: labeling and UDI

FDA source

Heartware, Inc. began a recall of HeartWare Ventricular Assist Device (HVAD) System on 2022-01-27. FDA classified it as Class II and gives the reason as "Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0726-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-27
Posted: 2022-03-04
Recalling firm: HeartWare, Inc.
Product: HeartWare Ventricular Assist Device (HVAD) System
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Starting 27-Jan-2022 and ending 02-FEB-2022, Medtronic initiated an Urgent Medical Device Notice to global customers to inform them of the intent to update the cleaning instructions for power source connector pins on the HVAD" System Monitor AC Adapter, DC Adapter, and Batteries. The communication provided customers the updated instructions, the complaints received as well as the potential hazards of cleaning the power source connector pins. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients. In the United States the notice was delivered to VAD Coordinators via UPS 2-day delivery. Consignees will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for those nonimplanted, affected product. In addition, a courtesy copy was sent to shared care clinics for those affected patients. Outside the United States the notice will be delivered to consignees through a locally approved method. Consignees will be asked to confirm receipt of the letter and that they have taken the recommended action. Confirmation of the communication will be received by locally approved methods.
Quantity in commerce: 197,889 units
Distribution: Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: All lots/serials for the following product model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650, 1650CA-CLIN, 1650DE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-04

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)