# FDA recall Z-1205-2025

> **Biosense Webster, Inc.** · Class I · device recall initiated 2025-01-05.

## 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.

## Reason for recall

Due to an observed trend of neurovascular events

## 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 Japan

## Key facts

- **Recall number:** Z-1205-2025
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-05
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2025

## Citation

> AI Analytics. FDA recall Z-1205-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1205-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*