Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly

Reason: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.

Code information: Affected Lot Numbers/Expiration Date: 19101020 /October 2020

Distribution pattern: US: CA,SC, AZ OUS: None