Acutus Medical recalls AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle due to possible foreign material particulates causing procedure delays or pulmonary embolism. Affected lot numbers: 19101020 (October 2: 2020).
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.
Acutus Medical is recalling a specific type of medical device that may have foreign material particulates. This could cause procedure delays or pulmonary embolism, a serious blood clot in the lungs.
Foreign material particulates may be present during manufacturing. If these particles enter the bloodstream during a procedure, they could cause blockages or pulmonary embolism, a life-threatening condition.
Healthcare professionals using this device during medical procedures are most at risk. Patients undergoing procedures with this device could be affected if the particulates cause complications.
Check for the product name 'Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle' and lot number 19101020 (October 2020).
Verify the lot number on the device packaging; affected units have lot number 19101020 (October 2020).
The recall states that foreign material particulates may be present, which could cause procedure delays or pulmonary embolism, but the device itself is not inherently dangerous if used correctly.
The recall does not specify a remedy, so contact Acutus Medical directly for guidance on next steps.
The recall indicates a potential risk of pulmonary embolism, so it is recommended to avoid using the device until further instructions are received.
We’ve drafted a message you can send Acutus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1771-2020 — Acutus Medical Acutus Medical Hello, I own a Acutus Medical that is covered by recall Z-1771-2020 from Acutus Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
