medical Class II Updated 2020-04-29

Acutus Medical Inc recalls Acutus Medical AcQGuide Flex Steerable Introducer with AcQcr

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, SC, AZ
Lot/Code Info: Affected Lot Numbers/Expiration Date: 19101020 /October 2020
View official government recall

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