Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Company
- Datascope Corp.
- Recall Initiated
- September 8, 2021
- Recall Number
- Z-2616-2021
- Quantity
- 3969 total (US); 3550 total (OUS)
- Firm Location
- Mahwah, NJ
Reason for Recall
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
Lot / Code Info
All lots
Root Cause
Software design
Action Taken
On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid experience the following issue: Unexpected Shutdown Upon Battery Removal. Immediate Actions to be taken by Customers: To ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when: - There is a singulat battery in either battery charging bay and unused battery bay is empty. - The battery is charging on AC power (indicated by a flashing LED on the battery pack). Additionally, the user can prevent the issue by ensuring that a battery is inserted into each of the two battery bays. Should a charging battery be ejected inadvertently, the unit will automatically switch over to the second battery, thus preventing system shutdown. Furthermore, Datascope/Getinge is developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).