FDA-Device2020-04-29Class II
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Acutus Medical Inc
Hazard
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.
Sold states
US: CA,SC, AZ OUS: None
Affected count
5 units
Manufactured in
2210 Faraday Ave Ste 100, N/A, Carlsbad, CA, United States
Products
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1771-2020Don't want to check this manually?
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