New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been hit with another recall by the manufacturer (Getinge/Datascope), this time due to damage to the balloon catheter that might permit blood to flow into the pump.

A “blood back event” could lead to a range of potentially fatal problems ranging from pump shutdown to blood-borne pathogen cross contamination, the US Food and Drug Administration warned in a recall notice today.

Getinge/Datascope initiated this particular recall in late December 2022, sending customers an Urgent Medical Device Recall letter; the FDA has categorized the action as a Class I recall, the most serious type. The company has received a total of 134 complaints including 12 device shutdowns, four serious injuries, and one death.

According to the FDA, “blood back events” pose potential risks of:

• Blood loss
• Contact with electrical components, leading to pump shutdown, which in turn can cause hemodynamic instability, organ damage and/or death
• Release of helium gas bubbles into the blood, potentially damaging organs, including the brain, if pump shutdown does not occur and therapy continues
• Exposure of patients or subsequent maintenance or service personnel to unexpected biohazards, if containment precautions aren’t followed
• Exposure of subsequent patients to cross contamination to blood-borne diseases, including hepatitis B, hepatitis C, and HIV

The Cardiosave devices have a history of Class I recalls, including one in December 2021 related to fluid leaks, close on the heels of an October 2021 recall related to battery problems. Prior actions were tied to potential electrical test failure (June 2017), failure of the device valve (August 2017), fluid ingress (September 2017 and June 2018), possible failure at high altitudes (November 2018), and potential battery failure (July 2019).

Any hospitals with either device in use are being told to examine their inventory for signs of a blood back event and to contact the manufacturer.