lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Check against the official notice below — it lists the full affected range.
Abiomed, Inc. is recalling one Impella CP with Smart Assist left heart support blood pump (Model 0048-0003, Serial Number 192148A) that was distributed to Georgia. The recalled pump shipped with incorrect programming that would have caused it to immediately run at its highest power level (P9) for all selected power settings, rather than gradually ramping up over 10 seconds. Additionally, the positioning and suction alarms on this pump were disabled, and the pump may have migrated out of position during use, potentially causing injury to the patient.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: The product was distributed to GA Quantity: 1 Lot/code info: UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.