Company: Abiomed, Inc.
Date of Enforcement Report: 11/13/2019
Class II

PRODUCT

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

• Recall Number: Z-0345-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Abiomed, Inc. on 9/4/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1

DISTRIBUTION

GA (United States)