FDA Issues Update on Cardiac Device Recall Due to Risk of Battery Failure

The FDA has issued an update on Datascope/Getinge/Maquet’s recall of its Cardiosave Hybrid/Rescue intra-aortic balloon pump battery packs, deeming it a Class 1 recall.

The cardiac assist device is for patients undergoing surgery or for patients who have acute coronary syndrome or complications of heart failure. The 137 faulty battery packs affected were distributed from Sept. 23, 2017, to Aug. 17.

The reason for the recall is the risk of a shortened run-time due to substandard batteries, which may cause the device to stop working.

There have been six complaints, but no reports of injuries or deaths related to the problem, the agency said.