Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

Detected March 16th, 2026

Summary

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding Impella AIC consoles with software versions less than 10.1, specifically when associated with first-generation Impella 5.5 ventricular assist devices. This alert, registered under number R2606924, indicates a safety action initiated by the manufacturer, Abiomed. The specific nature of the safety concern and the affected units are detailed in a letter sent directly to the users concerned.

Healthcare providers utilizing these specific Impella console and device configurations should review the safety communication from Abiomed, which was distributed on March 16, 2026. While the ANSM is relaying the information, direct engagement with Abiomed for any questions or required actions is advised. The document does not specify immediate compliance deadlines or penalties but implies a need for prompt review and adherence to manufacturer guidance to ensure patient safety and device efficacy.

What to do next

Review Abiomed's safety communication regarding Impella AIC consoles and Impella 5.5 first-gen devices.
Contact Abiomed directly for any specific questions or required actions related to the safety alert.

Source document (simplified)

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Information n° R2606924 destinée aux établissements de santé Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606924. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.

L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Abiomed.

Les utilisateurs concernés ont reçu le courrier ci-joint. Téléchargez le courrier de la société Abiomed (16/03/2026)