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Health Canada Medical devices

Impella® Controller

Issued August 29, 2025
Issue
Abiomed has identified specific automated Impella® controller in the field that have a pump driver circuit assembly that does not meet current specifications. These pump driver circuit assemblies contain 25v-rated tantalum capacitors instead of 35v-rated. These underrated capacitors may lead to decreased pump performance or pump stop and trigger an "Impella failure" or "Impella stopped. Controller failure." alarm. Recall start date: August 27, 2025
Hazard description
Performance
Product
Product name
Impella® Controller
Reference
ID
RA-78001