Recall Monitor
Health ProductsType I recall

Impella® Controller

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Impella® Controller
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Impella® ControllerIC15440042-0000-CA
Impella® ControllerIC15430042-0000-CA

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

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