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.
“Biosense Webster VARIPULSE Catheter Recall: Neurovascular Event Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53152-biosense-webster-varipulse-catheter-recall-neurovascular-event-risk. Based on FDA recall #Z-1205-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2025%22&limit=1).
The FDA announced on Jan. 5, 2025, that Biosense Webster, Inc. is recalling VARIPULSE Bi-Directional Ablation Catheters due to an observed trend of neurovascular events. The voluntary Class I recall affects 497 units distributed worldwide.
The recall is due to an observed trend of neurovascular events associated with the VARIPULSE Bi-Directional Ablation Catheter. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Biosense Webster, Inc. has had seven other recalls since June 14, 2017. Recent brand recalls include a Feb. 16, 2024 recall of CARTO VIZIGO Bi-Directional Guiding Sheaths due to a manufacturing mix-up and a Feb. 21, 2023 recall for incorrect labeling hazards. Other recent recalls of similar products include the Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus (July 9, 2026), Codman CerebroFlo EVD Catheter (April 10, 2026), and Getinge Thoracic Catheter (Aug. 7, 2026).
How to tell if you have this one
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.
Brand
Biosense Webster
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product code D141201-12 and batch numbers from the recall list to confirm if your catheter is affected.
Where it went and when
Where it was distributed
Distributed in 10 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX. EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China Austria Belgium Czech Republic France Germany Hungary Ireland Israel Italy…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Colorado, Kansas, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1205-2025 (January 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1205-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.