Class I Recall Issued For CARDIOSAVE Hybrid Intra-Aortic Balloon Pump

On June 6, Maquet Datascope Corp. issued a Class I recall for the CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), a cardiac assist device used for patients undergoing cardiac and non-cardiac surgery and patients with acute coronary syndrome or complications from heart failure, due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

In case of an interruption in therapy, Maquet Datascope Corp. instructs users to transfer the patient to an alternative IABP. If an alternative IABP is unavailable, manually inflate the IABP with air or helium and immediately aspirate. Affected customers will be contacted by Maquet Datascope Corp. to schedule on-site service of the IABP. Health care professionals and patients are encouraged to report adverse events related to the use of this product.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: ACC Advocacy, Acute Coronary Syndrome, Corrosion, Intra-Aortic Balloon Pumping, Heart-Assist Devices, Heart Failure, Equipment Failure

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