Primary source: What is a Medical Device Recall?
All Automated Impella Controllers are recommended for removal from where they are used or sold due to identified purge cassette recognition failures.
The purge cassette recognition issue can compromise patient safety by delaying necessary mechanical circulatory support during critical procedures.
Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.
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Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.
The FDA has issued an Early Alert regarding a high-risk device issue involving Automated Impella Controllers from Abiomed. The issue pertains to purge cassette recognition failures that can lead to delays in mechanical circulatory support, prompting a recommendation for removal of these devices from use or sale.
What changed: All Automated Impella Controllers are recommended for removal from where they are used or sold due to identified purge cassette recognition failures.
Why it matters: The purge cassette recognition issue can compromise patient safety by delaying necessary mechanical circulatory support during critical procedures.
Practical implication: Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.
Published from the regulator source ingestion pipeline after PV impact triage.
Initiate the update of labeling materials for Rasonque to reflect the new FDA approval and ensure compliance with reporting requirements for newly approved therapies.
Healthcare professionals must include daraxonrasib in adverse event reporting as the new treatment option is now available for eligible patients.
Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.
Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.
