Reported Mar 12, 2025 · Ongoing
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based…
Biosense Webster, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
- Lot codes and dates
- Product NumberD141201-12
- UDI-DI code10846835025460
- Batch Numbers
31483574L31483560L31483581L31483542L31487313L31483552L31483544L31487311L31483550L31483558L31483575L31483556L31487312L31483553L31483565L31483576L31483547L31487320L31483549L31483561L31483548L31483564L31483541L31483546L31483562L31483566L31483583L31483567L
- Amount recalled
- 497 total catheter - 378 US and 119 OUS
Where it was sold
Why it was recalled
Stop using this product now
Due to an observed trend of neurovascular events
Using this product could cause serious injury, illness or death — stop using it now.
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