Abiomed recalled 10,153 Automated Impella Controllers and related components due to potential cybersecurity vulnerabilities in the operating system. The recall spans multiple international product codes and was first issued for devices distributed nationwide and internationally. Providers should stop using the affected controllers and follow manufacturer instructions immediately.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Impella Controller is used to manage left heart support devices during critical cardiac procedures. The device is managed by clinicians in hospital settings.
Cybersecurity vulnerabilities in the operating system could affect device reliability and patient safety.
This recall is part of broader concerns about cybersecurity vulnerabilities in medical devices, with heightened focus on hospital networked systems.
Hospitals may delay procedures or replace equipment; patients could experience device-related interruptions.
Official recall notices and device labeling on the manufacturer's site and FDA enforcement reports.
Remedies typically take weeks to months depending on replacement availability.
Keep all recall communications, serial numbers, and replacement orders for records.
Product: Automated Impella Controller (AIC) and related optical controllers. Class I recall. Quantity: 10,153 units. Distribution: Nationwide in the U.S. and international. Product codes span 0042-0000 series, 0042-0010 series, 0042-0040 series, plus 1000201 and 1000432.
No injuries or incidents have been reported in the provided data.
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