FDA-Device2019-11-13Class II
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Abiomed, Inc.
Hazard
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.
Sold states
The product was distributed to GA
Affected count
1
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0345-2020Don't want to check this manually?
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