New Recall for Maquet/Datascope IABPs Due to Potential Battery Failure

Getinge is recalling numerous Maquet/Datascope intra-aortic balloon pumps (IABPs) due to potential battery failure during use that can lead to unexpected stopping and shortened run times.

Maquet/Datascope has received reports of five patient deaths since March 2016, but the company “has not concluded that the deaths are due solely to the device shutting down while operating on battery power,” according an alert from the US Food and Drug Administration.

The recall, which the FDA identified yesterday as Class I, affects all lots and manufacturing and distribution dates for the following IABP models: Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/100i.

No product return is required. Maquet/Datascope will schedule a training visit with every affected customer to discuss new guidance on conserving battery power and is also developing battery maintenance software. The target date for deploying this software, which will require FDA approval, is early 2020.

In an Urgent Medical Device Correction letter sent on June 17, 2019, Maquet/Datascope recommended using AC power when a device is not in use and whenever possible during use. For the Cardiosave Rescue and Hybrid models, the company also recommends having additional charged batteries available during patient transport and ensuring that the batteries are properly seated.

This latest recall continues a string of challenges for Maquet/Datascope IABPs. In 2017, the FDA elevated a field action to a Class I recall, following one patient death. In 2018, the Cardiosave Hybrid IABP warranted a Class I recall due to “fluid ingress.” Later that same year, the FDA reported yet another Class I recall, also potentially involving battery-related power problems at high altitudes.