System, Balloon, Intra-aortic And Control

Battery Charging Station;

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

CS100 IABP. Software Version CS100 IABP Q.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

CS300 IABP. Software Version CS300 IABP C.01.

The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

Cardiosave Hybrid

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Cardiosave Rescue

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Brand Name: Ultra IABP Catheter Kit

Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-

There is discrepant labeling on the inner and outer packaging of the device.

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.