Siemens recalls ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F due to left atrial perforations and Atrioventricular Node block. Affected units have specific serial numbers.
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
Siemens is recalling ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F models that have been linked to left atrial perforations and Atrioventricular Node block. This is a serious medical device hazard that requires immediate attention.
This catheter can cause holes in the heart's left atrium and disrupt the electrical signals between the heart's chambers, potentially leading to life-threatening arrhythmias or heart failure.
Healthcare professionals using this catheter for cardiac imaging are most at risk. Patients receiving procedures with this device may also be affected.
Check the serial numbers listed in the recall notice: XR000002 to XR000774. The product is used in cardiac imaging procedures by medical professionals.
Immediately stop using the recalled ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F if you have it.
The recalled model is ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F with specific serial numbers listed in the notice.
Check the serial number on your catheter against the list of affected serial numbers provided in the recall notice.
The recall notice does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0090-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0090-2021 from Siemens. 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.
