Recall Z-0345-2020 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
| Date | Sep 4, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1 |
| Distribution | The product was distributed to GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.