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)