Getinge subsidiary Datascope, a manufacturer of life-supporting medical devices, is recalling Cardiosave Hybrid intra-aortic balloon pumps (IABPs) and Rescue IABPs due to a compromised intra-aortic balloon causing blood to enter the IABP during therapy.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Cardiosave Hybrid IABP and Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through 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 right time during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac, and non-cardiac surgery, or complications of heart failure in adults.
Blood in the IABP pump can cause:
- An unexpected pump shutdown if blood contacts electrical components. This can lead to unstable blood flow, organ damage and/or death.
- If therapy continues, patients may have helium released into their blood. Helium gas bubbles (gas emboli) in the blood can damage organs (including the brain).
- Patient blood loss
- The user and/or subsequent maintenance or service personnel can be exposed to an unexpected biohazard should proper containment precautions not be taken.
- If the affected IABP is not evaluated before use with a new patient, that new patient may be exposed to cross-contaminated blood, which also exposes them to the potential for life-long bacterial and viral diseases such as hepatitis B, hepatitis C, and HIV.
Datascope and Getinge have reported 134 complaints about this issue, including 12 device shutdowns and 5 adverse events (4 serious injuries and 1 death). This recall affects 4,454 devices.