AcQMap for mapping the heart atria to target ablation treatment for arrhythmias

Regulatory information

AcQMap is a CE marked class IIb medical device.

The following manufacturer field safety notices or medical device alerts for this technology have been identified. In April 2020 there was a US Food and Drug Administration (FDA) device recall for the AcQGuide Flex Steerable Introducer and a US FDA recall for the AcQGuide Mini Fixed-Curve Introducer. The recalls were from the company and related to the manufacturing process potentially leaving foreign material particulates on the finished device. The company says that this fault has now been resolved.