Acutus Medical recalls Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle due to potential foreign material particulates causing procedure delays or pulmonary embolism. Affected lots: 19052006 (May 2020) and 19061318 (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 a specific medical device that may have foreign material particulates. This could cause procedure delays or pulmonary embolism during medical procedures. Patients using the recalled device should stop using it immediately.
The device may have foreign material particulates from the manufacturing process. These particulates could cause procedure delays or, in rare cases, lead to pulmonary embolism during medical procedures.
Healthcare professionals using the Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle for procedures are affected. Those with the specific lot numbers listed are at risk of procedure delays or pulmonary embolism.
Check the lot number on the device packaging. Affected lots are 19052006 (May 2020) and 19061318 (June 2020). The device is sold under the Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle name.
Look for the lot number on the device packaging to determine if it is affected (19052006 or 19061318).
The Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO.
Affected lot numbers are 19052006 (May 2020) and 19061318 (June 2020).
The device may have foreign material particulates from the manufacturing process, which could cause procedure delays or pulmonary embolism.
We’ve drafted a message you can send Acutus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1770-2020 — Acutus Medical Acutus Medical Hello, I own a Acutus Medical that is covered by recall Z-1770-2020 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.
