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 ControllerIC20340042-0000-CA
Impella ControllerIC15720042-0000-CA
Impella ControllerIC23690042-0000-CA
Impella ControllerIC23700042-0000-CA
Impella ControllerIC17150042-0000-CA
Impella ControllerIC49440042-0000-CA
Impella ControllerIC14800042-0000-CA
Impella ControllerIC15440042-0000-CA
Impella ControllerIC20320042-0000-CA
Impella ControllerIC16650042-0000-CA
Impella ControllerIC10980042-0000-US

Issue

Abiomed has decided to initiate a voluntary medical device recall (removal) for Automated Impella Controllers (AICs) in the field related to a design change that improves the AIC purge retainer fixture and addresses potential purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the AIC may need to be replaced.

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