Abiomed, Inc. recalls lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock…

Recall date

September 4, 2019

Source

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

Recall number

Z-0345-2020

FDA classification

Class II

Brand / firm

Abiomed, Inc.

Sold / distributed

The product was distributed to GA

Why it was recalled

This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.

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

What was recalled

lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI