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 catalog number
Impella® ControllerMore than 10 numbers, contact manufacturer.0042-0040-CA
Impella® ControllerMore than 10 numbers, contact manufacturer.0042-0000-CA

Issue

Abiomed has identified an Automated Impella Controller™ (AIC) issue that may impair the detection of an Impella® pump when connected to an AIC. The pump detection issue may occur with any of the Abiomed Impella® pumps and may occur during console-to-console transfer or case start. There is no visual alarm displayed on the AIC screen to indicate the detection issue in these situations. Recall start date: July 7, 2025

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