FDA-Device2023-08-09Class I
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Hazard
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
Sold states
US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.
Affected count
166 units
Manufactured in
22 &, 24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2281-2023More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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