Abiomed, Inc.: Medical Device Recalls in 2023

According to to data from the FDA, there were 11 medical device recalls made by Abiomed, Inc. in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

• Impella 5.0 intravascular micro axial blood pump, Product Number 005062
• Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
• Impella CP intravascular micro axial blood pump, Product Number 0048-0032
• Impella LD intravascular micro axial blood pump, Product Number 005082
• Impella 2.5 intravascular micro axial blood pump, Product Number 005042
• Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
• Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
• Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
• 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)
• Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
• Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.