Sam Brusco, Associate Editor01.27.23
The U.S. Food and Drug Administration (FDA) has identified Getinge’s December 19 recall of its Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP as Class I.
The Cardiosave Hybrid and Rescue IABPs are electromechanical systems to inflate and deflate intra-aortic balloons. They provide temporary support to the left ventricle via counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the correct time during the cardiac cycle.
Cardiosave IABPs are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.
Getinge subsidiary Datascope recalled the devices because a compromised intra-aortic balloon (burst, leaking, or torn) can cause blood to enter the IABP during therapy.
The pump can unexpectedly shut down if blood comes in contact with electrical components, leading to unstable blood flow, organ damage, and/or death—especially for those patients who are critically ill. If therapy continues, patients may have helium released into their blood, which can damage organs.
Patients can experience blood loss, or users/maintenance and service personnel could be exposed to an unexpected biohazard if proper containment precautions aren’t taken. Further, If the affected IABP is’nt evaluated before use with a new patient, that new patient may be exposed to cross-contaminated blood, which exposes them to the potential for life-long bacterial and viral diseases such as hepatitis B, hepatitis C, and HIV.
4,454 devices were recalled in the U.S., distributed from March 6, 2012 to the present. Thus far, Datascope/Getinge have reported 134 complaints about this problem, with 12 device shutdowns, four serious injuries, and one death.
Further actions to take can be found on the FDA website.
The Cardiosave Hybrid and Rescue IABPs are electromechanical systems to inflate and deflate intra-aortic balloons. They provide temporary support to the left ventricle via counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the correct time during the cardiac cycle.
Cardiosave IABPs are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.
Getinge subsidiary Datascope recalled the devices because a compromised intra-aortic balloon (burst, leaking, or torn) can cause blood to enter the IABP during therapy.
The pump can unexpectedly shut down if blood comes in contact with electrical components, leading to unstable blood flow, organ damage, and/or death—especially for those patients who are critically ill. If therapy continues, patients may have helium released into their blood, which can damage organs.
Patients can experience blood loss, or users/maintenance and service personnel could be exposed to an unexpected biohazard if proper containment precautions aren’t taken. Further, If the affected IABP is’nt evaluated before use with a new patient, that new patient may be exposed to cross-contaminated blood, which exposes them to the potential for life-long bacterial and viral diseases such as hepatitis B, hepatitis C, and HIV.
4,454 devices were recalled in the U.S., distributed from March 6, 2012 to the present. Thus far, Datascope/Getinge have reported 134 complaints about this problem, with 12 device shutdowns, four serious injuries, and one death.
Further actions to take can be found on the FDA website.
