Class I — Biosense Webster, Inc.
| Recalling firm | BIOSENSE WEBSTER, INC. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Completed |
| Reason | Due to an observed trend of neurovascular events |
| Product | 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. |
| Quantity | 497 total catheter - 378 US and 119 OUS |
| 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 UK Sweden Norway Denmark Finland Luxembourg Netherlands Poland Portugal Slovenia Spain Switzerland Serbia United Arab Emirates Croatia Canada South Korea Japa… |
| Initiated | 2025-01-05 |
| Classified | 2025-02-28 |
| Recall number | Z-1205-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Biosense Webster, Inc. (Z-1205-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96170/
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