lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
This recall has been terminated (originally issued September 4, 2019).
- Company
- Abiomed, Inc.
- Recall Initiated
- September 4, 2019
- Terminated
- January 21, 2020
- Recall Number
- Z-0345-2020
- Quantity
- 1
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
Root Cause
Under Investigation by firm
Action Taken
The affected device was retrieved from the only customer on 9/4/19. An Urgent Medical Device Recall notification letter dated 9/12/19 was sent to that customer as well.