FDA-Device2023-05-24Class I
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Abiomed, Inc.
Hazard
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Sold states
US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
Affected count
610 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1590-2023Don't want to check this manually?
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