Heartware, Inc. recalls HeartWare Model 1101

Recall date

November 29, 2022

Source

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

Recall number

Z-0743-2023

FDA classification

Class II

Brand / firm

Heartware, Inc.

Sold / distributed

Worldwide distribution.

Why it was recalled

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HeartWare Model 1101