Acutus Medical recalls AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator due to possible foreign material particulates causing procedure delays or pulmonary embolism. Affected lots from October 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 its AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle because manufacturing may have left foreign material on the device. This could cause procedure delays or pulmonary embolism during medical procedures.
Foreign material particulates from the manufacturing process could get into the bloodstream during medical procedures. This might cause procedure delays or pulmonary embolism, which is a serious condition where blood clots block the lungs.
Healthcare professionals using this device for medical procedures are most at risk. Patients undergoing procedures with this device may be affected if the device is used without proper cleaning.
Check for the product name 'Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle' and lot numbers 19101021, 19103124, or 19121604 from October 2020.
Look for lot numbers 19101021, 19103124, or 19121604 on the device packaging or label.
The device may have foreign material particulates that could cause procedure delays or pulmonary embolism, so it should not be used without checking the lot number.
The recall record does not specify a remedy, so contact Acutus Medical directly for guidance.
Check for lot numbers 19101021, 19103124, or 19121604 from October 2020 on the device packaging or label.
We’ve drafted a message you can send Acutus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2020 — Acutus Medical Acutus Medical Hello, I own a Acutus Medical that is covered by recall Z-1769-2020 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.
