Datascope/Getinge/Maquet Recalls Cardiosave Balloon Pump Battery

Serious events may result from the use of these devices. The FDA identified this as a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure Datascope/Getinge/Maquet is recalling this product due to the risk of unexpected short battery runtime in some battery packs. These batteries were unintentionally released to a limited number of customers. If a patient requires life-supporting therapy with an IABP and the device does not work or if therapy is stopped during use due to battery failure, the patient will be at risk of serious injury, including death. Both Cardiosave Hybrid and Rescue IABP monitors display battery life to the user, prompting intervention with low battery alarms when alternative power sources are indicated.  The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? Contact Datascope/Getinge/Maquet by calling Customer Service (1-888-943-8872, option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA