Reported Nov 13, 2019 · Terminated
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock…
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- lmpella CP with Smart Assist
- Model Number0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
- Lot codes and dates
- UDI(01)00813502011371(10)1430951(17)210331(21)192148A
- Serial Number192148A
- Amount recalled
- 1
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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