medical Class II Updated 2019-11-13

Abiomed, Inc. recalls lmpella CP with Smart Assist, Model Number: 0048-0003. Lef

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: GA
Lot/Code Info: UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
View official government recall

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