FDA-Device2023-08-09Class I
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Abiomed, Inc.
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-2281-2023Don't want to check this manually?
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