← FDA ENFORCEMENT
Z-1470-2026Class I
Abiomed, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Abiomed, Inc.
Product type
Device
Status
Ongoing
Report date
2026-03-11
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Firm state
MA
Product quantity
4,496 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Product description
Impella RP Flex with SmartAssist. Product Code: 1000323.
Code / lot info
Product Code: 1000323. UDI-DI: 00813502012811.
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →