Biosense Webster recalls VARIPULSE Bi-Directional Ablation Catheter REF D141201 due to observed trend of neurovascular events. Affected units include specific batch numbers and product codes.
Due to an observed trend of neurovascular events
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters with serial number D141201 because they have been linked to neurovascular events. This could cause serious harm during medical procedures.
The catheter has been associated with a trend of neurovascular events, which can include nerve or blood vessel damage. This risk occurs during cardiac electrophysiological mapping procedures when the catheter is used for treating atrial fibrillation.
Medical professionals using the catheter for cardiac procedures are most at risk. Patients undergoing treatment with this device may also be affected.
Check for product code D141201-12 and batch numbers listed in the recall notice. The catheter is used with the CARTO 3 System for cardiac procedures.
Identify the product code D141201-12 and batch numbers from the recall list to confirm if your catheter is affected.
The recall states there is an observed trend of neurovascular events, so it is not recommended for use until the recall is addressed.
Check the product code and batch numbers listed in the recall notice to determine if your catheter is affected.
The recall does not specify a replacement process or remedy, so contact Biosense Webster directly for assistance.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-1205-2025 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-1205-2025 from Biosense Webster. 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.
