Heartware, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2196-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

HeartWare HVAD Outflow Graft, REF MCS1725OG

Product Classification:

Class I

Date Initiated: June 3, 2021

Date Posted: August 18, 2021

Recall Number: Z-2196-2021

Event ID: 88197

Reason for Recall:

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

Status: Ongoing

Product Quantity: 459 units

Code Information:

GTIN: 00888707007627, 00888707007634 All serial numbers

Distribution Pattern:

Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated