Recall Z-0345-2020— Abiomed, Inc.
Class II · Terminated
Class II FDA medical device recall by Abiomed, Inc., initiated 2019-09-04, terminated 2020-01-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-04
- Terminated
- 2020-01-21
- Firm location
- Danvers, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.