Z-0345-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- September 4, 2019
- Termination Date
- January 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
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 Pattern
The product was distributed to GA
Code Information
UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A