Medical device manufacturer Abiomed has initiated a recall of Automated Impella Controllers following FDA notification of a critical safety issue. The devices, used to support patients with severe heart failure, are experiencing purge cassette recognition failures that may delay or prevent proper mechanical circulatory support delivery.
The malfunction poses significant risk to patients dependent on these controllers for cardiac assistance. Abiomed has notified healthcare facilities and clinicians of the recall. Affected institutions should immediately verify their inventory and assess any devices currently in use or storage.
The FDA and Abiomed are working to address the issue and provide guidance to medical centers. Healthcare providers should contact Abiomed directly for specific instructions regarding affected units and replacement protocols. Patients with implanted devices should consult their cardiologists regarding their device status. This is a developing story.
Source: Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
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