Recall Monitor
Health ProductsType I recall

Automated Impella Controller

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Automated 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
Automated Impella ControllerSoftware version 8.2.30042-0040-CA
Automated Impella ControllerSoftware version 8.2.30042-0000-CA

Issue

Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed. Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.

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