Heartware recalls HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline…

Recall date

March 10, 2017

Source

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

Recall number

Z-1832-2017

FDA classification

Class I

Brand / firm

Heartware

Sold / distributed

Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.

Why it was recalled

In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.

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 Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).