FDA Issues Urgent Recall Alert for Getinge Cardiosave Intra-Aortic Balloon Pumps and Getinge/Maquet Cardiohelp system

We continue investigating heart-related medical devices. On May 8th, FDA announced an alert to health care providers and facilities regarding the following Getinge/Maquet cardiovascular medical devices:

• Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and
• Getinge/Maquet Cardiohelp system and HLS Sets.

The FDA Recall Notice Details Concerning Getinge/Maquet/Datascope Cardiosave Getinge/Maquet Cardiohelp

FDA reached out to healthcare providers and patients regarding a critical recall of Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs). This is not the first recall.

• Review the FDA’s previous recommendations. FDA recommends reading any Urgent Medical Device Correction notices from Getinge and follow the recommendations.
• Be aware of the recalls related to these devices.

The U.S. Food and Drug Administration (FDA) has classified these recalls as Class I. This is the most serious kind of recall. It indicates a situation where there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.

Bases for the Getinge/Maquet Recall

There are at least 26 reports of device complaints. The reported adverse events do not include deaths or injuries.

Specifically, the recalls are due to unexpected shutdowns of the devices, stemming from various mechanical and electrical failures. These failures include issues with the Power Management Board, Solenoid Board, and failures in the device’s ability to refill helium necessary for operation.

Impact and Actions Taken

The recall concerns over 4,586 devices. The company distributed them in the U.S. The devices support patients with acute coronary syndrome. Doctors use them during cardiac and non-cardiac surgeries. The FDA has advised healthcare providers to have alternative IABP devices available and to explore other forms of hemodynamic support to continue essential therapy.

Legal Perspective and Patient Advocacy

Our firm handles medical device litigation. We understand the gravity of these failures and the potential risks they pose to patient safety. Our firm has decades of experience in litigating cases involving defective medical devices, and we have played significant roles in Multidistrict Litigations (MDLs), including leadership positions. Our experience extends to trying bellwether cases that set precedents in medical device litigation.

Investigation and How We May Help You

We are currently investigating Getinge Maquet Cardiohelp Cardiosave Intra-Aortic Balloon Pumps, along with other heart-related device cases. This includes Impella and HeartMate.

Conclusion

It is crucial for healthcare providers to adhere to the FDA’s recommendations and for patients to be aware of the potential risks associated with these devices. Our firm is dedicated to advocating for the rights and safety of patients, and we are here to assist those impacted by these device recalls.

For more detailed information on the recalls and affected devices, please visit the FDA’s official recall notificatio at https://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps and contact us directly to discuss any concerns or legal questions you may have regarding these issues.