Recall Z-3135-2024

Reason for recall

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.

FDA-determined cause: Software design

Action taken

Consignees were mailed an URGENT FIELD SAFETY NOTICE dated 8/5/2024. This notification informs consignees of the deployment of previously installed software to mitigate previously identified issues in Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump devices. Consignees are asked to examine their inventory immediately to identify if they have any Cardiosave Hybrid and/or Rescue IABP devices, and to identify what software version is currently installed in devices. Devices with software revision D.00 or D.01 have been corrected. If consignee units have a software version lower than D.00 or D.01 (e.g.: B.XX or C.XX) the device still requires the software update and has not yet been corrected. If consignee units do not have the corrected software revision installed, they are to continue to follow the instructions as listed int he original recall notification until the affected device(s) has been updated. Consignees are to complete and return the provided Response Form to the provided email address. Datascope/Getinge service representatives will contact consignees to schedule installation of software, if needed. Consignees are to forward the recall notice to all device users in their facility and to any customers to whom the device was shipped.