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Abiomed, Inc. recalls Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s
Recalled May 24, 2023 · FDA recall Z-1590-2023 · Abiomed
Hazard
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. · FDA Class I
Units
610 units
Sold at
US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
Description
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Product
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)
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →