Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Impella RP Flex with SmartAssist intracardiac microaxial blood pump Recalled by Abiomed, Inc. Due to A higher than expected rate of thrombus formation...
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
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Quantity: 166 units
Why Was This Recalled?
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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