FDA Device recall Z-0345-2020
lmpella CP with Smart Assist, Model Number: 0048-0003
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of lmpella CP with Smart Assist, Model Number: 0048-0003 by Abiomed, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0345-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-04 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abiomed |
| Distribution | GA |
Product
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
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.
Identifiers
| code_info | UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0345-2020%22
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