Home / Recalls / Biosense Webster, Inc. / Z-1205-2025

Z-1205-2025 Class I Ongoing

Recalled by Biosense Webster, Inc. — Irvine, CA

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
January 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
497 total catheter - 378 US and 119 OUS

Product Description

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 Pattern

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

Code Information

Product Number: D141201-12 UDI-DI code: 10846835025460 Batch Numbers: 31483574L 31483560L 31483581L 31483542L 31487313L 31483552L 31483544L 31487311L 31483550L 31483558L 31483575L 31483556L 31487312L 31483553L 31483565L 31483576L 31483547L 31487320L 31483549L 31483561L 31483548L 31483564L 31483541L 31483546L 31483562L 31483566L 31483583L 31483567L

Other recalls by Biosense Webster, Inc.

  • Z-1290-2024 Class II — CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM B (February 16, 2024)
  • Z-1320-2023 Class II — Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D (February 21, 2023)
  • Z-1319-2023 Class II — Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D- (February 21, 2023)
  • Z-1677-2022 Class II — CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduc (June 29, 2022)
  • Z-1285-2021 Class II — Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, (February 26, 2021)
  • Z-1287-2021 Class II — Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, (February 26, 2021)
  • Z-1286-2021 Class II — Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, (February 26, 2021)
  • Z-2371-2020 Class II — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE (April 22, 2020)
  • Z-2372-2020 Class II — PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STER (April 22, 2020)
  • Z-2878-2018 Class I — WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers (May 7, 2018)