Datascope Corp. is recalling 11,621 Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to reports of 'System Over Temperature' alarms. This defect can cause the life-sustaining device to stop pumping suddenly or enter a standby mode, which can lead to unstable blood flow in critically ill patients. The recall affects devices distributed nationwide and worldwide, specifically including 5,455 units in the United States and 6,166 units internationally. While the firm initiated this recall via a notification letter, consumers should contact their healthcare provider or the manufacturer immediately for further instructions.
The device can overheat, triggering a system alarm that causes an immediate loss of mechanical circulatory support. For patients relying on this device for heart function, a sudden interruption in pumping can lead to organ damage, heart failure, or death.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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