Another Recall of Balloon Pumps Following Reported Death

Posted by Burg Simpson Ohio:

Another Recall of Getinge / Maquet / Datascope Balloon Pumps Following Reported Death

On January 5, 2022, the FDA announced that another batch of Getinge / Maquet / Datascope Cardiosave intra-aortic balloon pumps are being recalled, this time due to complaints of fluid leaks that may cause the balloon pumps to shut down or fail to assist the heart as intended. The balloon pump are designed to provide blood-pumping assistance to the hearts of critically ill or injured patients. However, the Cardiosave Hybrid and Cardiosave Rescue units feature electronic components that could be exposed to leaking liquids. If a spill occurs, the liquid (e.g. saline) could enter the unit at certain locations and short electrical circuits, which may lead to an unexpected shutdown. The unit’s susceptibility to liquid entry has led to fear that the pumps could shut down when it matters most. There have been over 70 complaints and, sadly, a reported death associated with this issue.

This is just the latest in a string of issues with the Cardiosave intra-aortic balloon pumps that have prompted FDA action. Indeed, once in 2018 and again in 2019, the FDA circulated letters warning healthcare providers about reports of Getinge / Maquete / Datascope intra-aortic balloon pumps unexpectedly shutting down while running on battery power. Burg Simpson previously wrote about those Warning Letters here. Now, since September 2021, Getinge has announced three voluntary recalls related to the potential for the failure of Cardiosave Hybrid and Rescue intra-aortic balloon pump units. More information on intra-aortic balloon pumps can be found below.

What is an intra-aortic balloon pump?

An intra-aortic balloon pump, or “IABP”, is a mechanical unit that helps the heart pump blood. The unit consists of a pump itself, a catheter and a balloon. The catheter is a long thin tube that is positioned in the patient’s aorta, the artery that takes blood from the heart to the rest of the body. On the other end of the catheter is a balloon that inflates and deflates to the beat of the patient’s heart. When working as intended, the balloon pump will reduce the strain on the patient’s heart by assisting the heart in pumping blood to the rest of the body.

When are intra-aortic balloon pumps used?

 Intra-aortic balloon pumps are used in critically ill or injured patients in healthcare facilities and during transport. The pumps are commonly used during surgery and to treat patients with acute coronary syndrome or complications from heart failure.

What are the risks of intra-aortic balloon pump failure?

 If the intra-aortic balloon pump fails, the unit will stop assisting in the pumping of blood and the patient may lose circulatory support. For those critically ill or injured patients requiring the pump for life-supporting therapy, the consequences can be grave. In addition to reports of patient deaths, the FDA has received accounts of patients experiencing severe drops in blood pressure and the need for resuscitation.

If you or a loved one has suffered injuries that you suspect could be attributed to the failure of an intra-aortic balloon pump, contact one of the experienced medical device attorneys at Burg Simpson’s Ohio office today. Our award-winning lawyers have a proven history of results for thousands of clients nationwide. They possess the knowledge, resources, and skill needed to get you the justice and compensation you deserve. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.