Patient deaths, battery failures push recall of Cardiosave intra-aortic balloon pumps
Maquet and Datascope issued a nationwide recall of 22,853 intra-aortic balloon pumps (IABPs) July 23 following reports of five patient deaths and numerous battery failures.
The FDA identified the recall, which affects all lots of the Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100/100i IABP, as Class I, suggesting use of the Maquet/Datascope devices could result in serious injury or death. According to a statement, the companies recalled all IABPs due to reports of IABP batteries failing to hold a charge, stopping unexpectedly and having a shortened run-time.
Faulty batteries could cause the device to stop working altogether if it’s being operated solely by battery power, meaning patients who rely on IABPs as life-supporting therapies could be at major risk for adverse events.
“This recall is being conducted to ensure that all IABP users and services 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,” Maquet/Datascope’s statement read. “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.”
The companies said they’d been made aware of five total patient deaths since March 2016, though they haven’t concluded those deaths were necessarily connected to battery failure.
Maquet/Datascope reportedly sent customers affected by the recall an “Urgent Medical Device Correction” notice June 17 informing them of the potential risks associated with their IABPs. According to the companies’ statement, they’ll be contacting each affected customer to schedule a training visit to review a recently developed battery operations, care and maintenance reference guide.
Find more information about the recall here.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.