Global Recall for Maquet/Datascope Intra-aortic Balloon Pumps

Patrice Wendling

July 24, 2019

Maquet/Datascope is recalling all intra-aortic balloon pumps (IABPs) after reports of the batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time, according to the US Food and Drug Administration (FDA).

The agency classified the global recall as class 1, the most serious type, because of the potential risk for "serious injury, including death" if the device does not work or if therapy is stopped during use because of battery failure.

"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," the FDA writes in the July 23 safety alert.

The recall includes all lots of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/100i IABPs. The FDA notes that 22,853 devices are to be recalled in the United States alone, with all manufacturing and distribution dates affected.

Maquet/Datascope, a subsidiary of Getinge, notified its customers on June 17, 2019, via an urgent medical device correction notice, of the potential risk for battery failure and provided instructions on how to minimize patient harm.

As previously reported, the FDA issued a warning in November 2018 of possible battery failure with the Maquet/Datascope IABPs after receiving more than 75 reports of the devices shutting down while operating on its rechargeable batteries since 2017.

"The cost for the recall is not material and is being conducted to ensure all IABP users 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 (i.e., no replacement of batteries)," Getinge spokesperson Anna Appelqvist told | Medscape Cardiology via email.

The recall involves 3674 Cardiosave units in the United States and 2367 outside the United States, and 6232 CS100/300 units inside and 10,344 outside the United States, she said.

Maquet/Datascope is developing a Cardiosave battery maintenance software upgrade targeted for early 2020, and will contact customers to schedule a free installation after FDA clearance of the software. A similar software upgrade was released for the CS300 IABP and CS100 IABP in 2017.

Customers with questions about the 2017 software update or the current recall can contact Maquet/Datascope technical support department at 1-888-627-8383 (select option "3") from 8:00 AM to 6:00 PM (Eastern Time), Monday through Friday.

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