Heartware, Inc. recalls HeartWare HVAD Driveline Extension Cable, REF 100

Recall date

June 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2192-2021

FDA classification

Class I

Brand / firm

Heartware, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HeartWare HVAD Driveline Extension Cable, REF 100