Acutus Medical recalls Rhythm Xience Guider Catheter Introducer with Lancer Integrated Dilator/Transseptal Needle due to potential foreign material particulates causing procedure delays or pulmonary embolism. Affected lots from April to June 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 Rhythm Xience Guider Catheter Introducers with Lancer Integrated Dilator/Transseptal Needle because manufacturing may have left foreign particles that could cause procedure delays or pulmonary embolism. This recall affects medical devices used in cardiac procedures.
Foreign material particulates from the manufacturing process could get into the device during use. This might cause procedure delays or, in rare cases, lead to pulmonary embolism where blood clots block the lungs.
Healthcare professionals using the Rhythm Xience Guider Catheter Introducer with Lancer Integrated Dilator/Transseptal Needle for cardiac procedures are most at risk. Patients undergoing these procedures may also be affected if the device is used.
Check for the product name 'Rhythm Xience Guider Catheter Introducer with Lancer Integrated Dilator/Transseptal Needle' and lot numbers 19040503 (April 2020), 19052007 (May 2020), or 19061317 (June 2020).
Look for the lot numbers 19040503, 19052007, or 19061317 on the device packaging or label.
The device may have foreign material particulates that could cause procedure delays or pulmonary embolism in rare cases.
Check for lot numbers 19040503 (April 2020), 19052007 (May 2020), or 19061317 (June 2020) on the device packaging or label.
The recall does not specify a remedy, so contact Acutus Medical directly for guidance.
We’ve drafted a message you can send Acutus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1768-2020 — Acutus Medical Acutus Medical Hello, I own a Acutus Medical that is covered by recall Z-1768-2020 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.
