The FDA on Jan. 25 announced a class 1 recall of Datascope/Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump after one death and four serious injuries were reported.
A class 1 recall notice is the most serious classification of recall, meaning the device could cause serious injury or death. This device is used to treat adults with heart failure complications or acute coronary syndrome.
Faulty IABPs can unexpectedly shut down during therapy if the balloon bursts, leaks or tears, allowing blood to come in contact with the device's electrical components. "Datascope/Getinge has reported 134 complaints about this issue, including 12 device shutdowns and five adverse events (four serious injuries and one death)," according to the FDA recall notice.
Device shutdowns during therapy can lead to patient blood loss, unstable blood flow, organ damage and possibly death. If therapy continues while blood is in the pump, there is a risk patients may have helium released into their blood, which could cause significant organ damage, according to the FDA recall notice.
"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," according to the FDA.
When the IABP malfunctions, service personnel may also face a potential biohazard risk.
The FDA's class 1 recall notice comes after Swedish medical device-maker Getinge issued two other recalls related to this device in 2022.
The first recall of the device came on Nov. 1, 2022, when Getinge recalled 137 of the IABP's battery packs after finding they don't work properly and could cause the device to stop working.
A second recall was announced Dec. 16, 2022, after Getinge received notice of one death and four serious injuries attributed to the faulty device. At the time, the company recalled 4,338 devices after discovering fluid leaks that can lead to unexpected shutdowns or the inability to initiate therapy.
To date, 4,454 of Getinge's IABP devices have been recalled in the U.S.