The IABP batteries failed to hold a charge, stopped unexpectedly, or had a shortened run-time, which may have caused the device to stop working when being operated by battery only, according to the FDA.
The devices are used to treat patients with acute coronary syndrome or complications from heart failure while undergoing surgery. In critical patients with severely compromised hemodynamic function dependent on continuous circulatory support, an interruption or delay in IAB support due to an unexpected shutdown or failure to initiate therapy can have severe, life-threatening consequences, the agency said. The FDA has labeled the recall Class I, adding that the deaths cannot be definitively attributed to the device shutting down while operating on battery power.
The recall covers 22,853 Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i IABP devices. Getinge began the recall May 16, 2019 to ensure that all IABP users and servicers follow each device’s operating instructions regarding usage, charging, maintenance and storage of the batteries, as battery run times and discharge cycles vary between IABP models. If battery maintenance is not performed for each IABP, the battery may not provide the expected minimum run time of operating power, the FDA said.
Maquet/Datascope is developing a Cardiosave battery maintenance software upgrade targeted for early 2020. This updated software requires FDA clearance and once completed, a Maquet/Datascope service representative will contact customers to schedule the installation of the updated software at no cost, the agency said.