On January 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Datascope is recalling its Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Rescue IABPs. Datascope had distributed 4,454 of the devices since March 6, 2012. At the time of the recall, the company had reported 134 complaints, including 12 device shutdowns, 4 serious injuries and 1 death.
IABPs are therapeutic devices that control blood flow from the heart by helping the heart pump more blood. The electromechanical systems are used in health care facilities to inflate and deflate intra-aortic balloons, for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. A thin, flexible catheter connects a balloon to a computer console. The balloon is positioned in the aorta. The pump is then set to make the balloon inflate and deflate in accord with the cardiac cycle.
The first clinical use of an IABP was reported in 1968. Twenty years later, it was the most commonly used cardiac assist device. Today, IABPs remain an option for temporary mechanical circulatory support (MCS) in response to cardiogenic shock. Most uses are for a few days, for recovering patients.
The Datascope recall is Class I, the most serious type of recall, indicating that there is a reasonable probability that the device could cause serious injury or death. Datascope recalled the pumps because intra-aortic balloons were compromised. If a balloon bursts, leaks, or is torn, it potentially allows blood to enter the IABP during therapy. Blood in the IABP (a “blood back event”) poses multiple risks, including:
- Device shutdown, potentially leading to hemodynamic instability (unstable blood flow), organ damage or death.
- Release of helium gas bubbles (gas emboli) in to the patient’s blood, potentially damaging organs including the brain.
- Patient blood loss.
- Contamination, exposing the patient, users and maintenance personnel to biohazards, bacterial diseases and viral diseases, including hepatitis B, hepatitis C, and HIV.
Datascope has recalled IABPs multiple times:
- Fluid leaks have prompted multiple recalls. On January 5, 2022, the FDA identified a Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue IABPs manufactured since 2011 due to complaint of fluid leaks, which caused pump shutdown. On December 22, 2021, the FDA classified an earlier recall as Class I, after 71 complaints were received about fluid leaks from the device, including links to one patient’s death.
- Battery failures have prompted multiple recalls. On October 29, 2021, the FDA announced a recall of certain models due to substandard batteries failing and having a shortened run-time, which could cause the device to stop. Six complaints had been filed. On July 24, 2019, the the FDA had issued a Class I recall for 22,853 IABPs, due to reports of battery failure. At that time, Datascope was aware of five patient deaths since March 2016.
- In September 2018, the FDA announced a recall because IABP devices failed at high altitude. In the prior two years, the FDA had received FDA has 75 reports of device shut downs, including three patient deaths.
Datascope Corp. produces and sells clinical health care equipment worldwide, in fields including interventional cardiology, anesthesiology, cardiovascular and vascular surgery, and critical care. Getinge AB is a global medical technology company, founded in Sweden in 1904. It has grown through a series of acquisitions, including Datascope, which was founded in 1964 in New Jersey. The companies announced their merger in 2009. After selling its endoscopic vessel harvesting product line to comply with a U.S. Federal Trade Commisson (FTC) settlement, Datscope became a part of Getinge’s Maquet Cardiovascular.
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