Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
lmpella CP with Smart Assist Recalled by Abiomed, Inc. Due to This one pump shipped with incorrect pump programming,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abiomed, Inc. directly.
Affected Products
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Quantity: 1
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: GA
About Abiomed, Inc.
Abiomed, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report