Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump Recall Issued Due to Risk Blood May Enter Catheter

Following dozens of reported involving problems with Cardiovase aortic balloon pumps, including at least one death, federal safety regulators have announced a Class I recall, indicating that the devices may be prone to burst or shut down unexpectedly during life-saving treatment.

The U.S. Food and Drug Administration (FDA) announced the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) recall this month, warning customers to be aware of alarms and signs of balloon tears, which could lead to life-threatening consequences for patients.

To date, the manufacturer has received 134 complaints involving balloon failures, resulting in 12 unexpected device shutdowns, four serious injuries and at least one death.

The cardiac assist devices are used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.

The recalled IABPs are designed to help the patient’s heart pump more blood throughout the body. The devices consist of a catheter that has a long balloon attached to one end, and a computer console at the other end. The console is programmed to inflate and deflate the balloon at the proper rate when the heart beats to help circulate blood flow.

According to the FDA’s Class I recall notice, the device’s intra-aortic balloon may become compromised, allowing the balloon to burst, leak or become torn. Officials warn this may lead to blood entering the IAB during therapy, causing the following issues;

• The pump may shut down unexpectedly if blood enters the electrical components, which may lead to unstable blood flow, organ damage, or death.
• Helium may be released into the patients’ blood causing a gas emboli, increasing the risk of organ damage
• Patient blood loss
• Exposing medical staff to unexpected biohazards
• Subsequent use of a defective pump on a new patient may pose a blood cross-contamination hazard, increasing the risk of unintentional transmission of bacterial and viral diseases such as hepatitis B, hepatitis C, and HIV.

The manufacturer Datascope/Getinge alerted customers about the issue on December 19, 2022, through an Urgent Medical Device Recall letter, instructing users to not bypass intra-aortic balloon (IAB) alarms and pay close attention to alarm notifications as that may help identify a perforated balloon earlier and prevent blood from traveling into the IABP.

Further recommendations included periodically checking the IAB catheter tubing for blood. The manufacturer issued a series of instructions to follow if blood is detected in the tubing.

Customers with questions or concerns regarding the recall are being encouraged to contact their Datascope/Getinge representative or call Datascope/Getinge Technical Support at 1-888-943-8872. Consumers who experienced any side effects or adverse events while using the device should report it to the FDA’s MedWatch Adverse Event Reporting Program.