lmpella CP with Smart Assist recall
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Why was lmpella CP with Smart Assist 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00813502011371(10)1430951(17)210331(21)192148A; Serial Number: 192148A
- Product
- lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
- Recalling firm
- Abiomed, Inc.
- Quantity
- 1
- Distribution
- The product was distributed to GA
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)