Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Recalled by Acutus Medical Inc Due to Foreign Object Contamination
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Acutus Medical Inc directly.
Affected Products
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Quantity: 5 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: AZ, CA, SC
About Acutus Medical Inc
Acutus Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report