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Overview

Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure

Maquet/Datascope is recalling all IABPs due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time which may cause the device to stop working when being operated by battery only. This recall is being conducted to ensure that all IABP users and servicers follow each device’s Operating Instructions Manual for recommendations on 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 per the Operating Instructions Manual for each IABP, the battery may not provide the expected minimum run time of operating power.

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.

Maquet/Datascope is aware of five patient deaths since March 2016, although the firm has not concluded that the deaths are due solely to the device shutting down while operating on battery power

For more information visit: https://www.fda.gov/medical-devices/medical-device-recalls/datascopegetinge-recalls-cardiosave-hybrid-cardiosave-rescue-cs300-and-cs100100i-intra-aortic?utm_campaign=2019-07-23%20Datascope%20Recalls%20Intra-Aortic%20Balloon%20Pumps%20Due%20to%20Battery%20Risk&utm_medium=email&utm_source=Eloqua

 

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